<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03000673</url>
  </required_header>
  <id_info>
    <org_study_id>CV010-010</org_study_id>
    <nct_id>NCT03000673</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate Safety of Single Doses of BMS-986177 in Patients With End Stage Renal Disease (ESRD) Treated With Hemodialysis</brief_title>
  <official_title>A Study to Assess Safety and Tolerability of Single Oral Doses of BMS-986177 in Patients With ESRD Treated With Chronic Hemodialysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bristol-Myers Squibb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To investigate safety of Single Doses of BMS-986177 in Patients with End Stage Renal Disease&#xD;
      treated with hemodialysis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 23, 2017</start_date>
  <completion_date type="Actual">October 23, 2017</completion_date>
  <primary_completion_date type="Actual">October 23, 2017</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death</measure>
    <time_frame>From the date of patient's written consent to participate in study until 30 days after discontinuation of dosing or patient's participation in study (up to October 2017)</time_frame>
    <description>Safety and tolerability of single oral doses of BMS-986177 in patients with end-stage renal disease (ESRD) on chronic hemodialysis (HD) treatment as measured by the number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation and death</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation</measure>
    <time_frame>At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.</time_frame>
    <description>HEMATOLOGY I; HEMOGLOBIN HB G/DL LOW &lt; 0.85*PRE-RX; HEMATOCRIT HCT % LOW &lt; 0.85*PRE-RX; PLATELET COUNT PLAT X10*9 C/L LOW &lt; 0.85*LLN IF PRE-RX IS MISSING; &lt; 0.85*LLN IF PRE-RX &gt;= LLN; &lt; 0.85*PRE-RX IF PRE-RX &lt; LLN; HIGH &gt; 1.5*ULN; HEMATOLOGY II; LEUKOCYTES WBC X10*3 C/UL LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF LLN &lt;= PRE-RX &lt;= ULN; &lt; 0.85*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.2*ULN IF PRE-RX IS MISSING; &gt; 1.2*ULN IF LLN &lt;= PRE-RX &lt;= ULN; &gt; 1.5*PRE-RX IF PRE-RX &gt; ULN; NEUTROPHILS (ABSOLUTE) NEUTA X10*3 C/UL LOW &lt; 1.5 IF PRE-RX IS MISSING; &lt; 1.5 IF PRE-RX &gt;= 1.5; &lt; 0.85*PRE-RX IF; PRE-RX &lt; 1.5; LYMPHOCYTES (ABSOLUTE) LYMPA X10*3 C/UL LOW &lt; 0.75; HIGH &gt; 7.5; MONOCYTES (ABSOLUTE) MONOA X10*3 C/UL HIGH &gt; 2; BASOPHILS (ABSOLUTE) BASOA X10*3 C/UL HIGH &gt; 0.4; EOSINOPHILS (ABSOLUTE) EOSA X10*3 C/UL HIGH &gt; 0.75; COAGULATION: PROTHROMBIN TIME (PT) PT SEC HIGH &gt; 1.5*ULN; APTT APTT SEC HIGH &gt; 1.5*ULN; INTL NORMALIZED RATIO (INR) INR FRACTION HIGH &gt; 1.5*ULN;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function</measure>
    <time_frame>At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.</time_frame>
    <description>LIVER &amp; KIDNEY FUNCTION; ALKALINE PHOSPHATASE (ALP) ALP U/L HIGH &gt; 1.25*ULN IF PRE-RX IS MISSING; &gt; 1.25*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L HIGH &gt; 1.25*ULN IF PRE-RX IS MISSING; &gt; 1.25*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L HIGH &gt; 1.25*ULN IF PRE-RX IS MISSING; &gt; 1.25*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; BILIRUBIN, TOTAL TBILI MG/DL HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; BILIRUBIN, DIRECT DBILI MG/DL HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; BLOOD UREA NITROGEN BUN MG/DL HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.2*PRE-RX IF PRE-RX &gt; ULN; CREATININE CREAT MG/DL HIGH &gt; 1.5*ULN IF PRE-RX IS MISSING; &gt; 1.5*ULN IF PRE-RX &lt;= ULN; &gt; 1.33*PRE-RX IF PRE-RX &gt; ULN;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes</measure>
    <time_frame>At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge</time_frame>
    <description>ELECTROLYTES: SODIUM, SERUM NA MEQ/L LOW &lt; 0.95*LLN IF PRE-RX IS MISSING; &lt; 0.95*LLN IF PRE-RX &gt;= LLN; &lt; 0.95*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.05*ULN IF PRE-RX IS MISSING; &gt; 1.05*ULN IF PRE-RX &lt;= ULN; &gt; 1.05*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; POTASSIUM, SERUM K MEQ/L LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.1*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; CHLORIDE, SERUM CL MEQ/L LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.1*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN;</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)</measure>
    <time_frame>At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.</time_frame>
    <description>ELECTROLYTES (CONT.): CALCIUM, TOTAL CA MG/DL LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.1*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; PHOSPHORUS, INORGANIC PHOS MG/DL LOW &lt; 0.85*LLN IF PRE-RX IS MISSING; &lt; 0.85*LLN IF PRE-RX &gt;= LLN; &lt; 0.85*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.25*ULN IF PRE-RX IS MISSING; &gt; 1.25*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; MAGNESIUM, SERUM MG MEQ/L LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.1*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing</measure>
    <time_frame>At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.</time_frame>
    <description>GLUCOSE, FASTING SERUM GLUCF MG/DL LOW &lt; 0.8*LLN IF PRE-RX IS MISSING; &lt; 0.8*LLN IF PRE-RX &gt;= LLN; &lt; 0.8*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.3*ULN IF PRE-RX IS MISSING &gt; 1.3*ULN IF PRE-RX &lt;= ULN; &gt; 2*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; PROTEIN, TOTAL TPRO G/DL LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.1*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; ALBUMIN ALB G/DL LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; CREATINE KINASE (CK) CK U/L HIGH &gt; 1.5*ULN IF PRE-RX IS MISSING; &gt; 1.5*ULN IF PRE-RX &lt;= ULN; &gt; 1.5*PRE-RX IF PRE-RX &gt; ULN; URIC ACID URIC MG/DL HIGH &gt; 1.2*ULN IF PRE-RX IS MISSING; &gt; 1.2*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; LACTATE DEHYDR (LD) LD U/L HIGH &gt; 1.25*ULN IF PRE-RX IS MISSING; &gt; 1.25*ULN IF PRE-RX &lt;= ULN; &gt; 1.5*PRE-RX IF PRE-RX &gt; ULN</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies</measure>
    <time_frame>At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.</time_frame>
    <description>URINALYSIS I; BLOOD, URINE UBLD N/A HIGH &gt;= 2 IF PRE-RX IS MISSING; &gt;= 2 IF PRE-RX &lt; 1; &gt;= 2 IF PRE-RX &gt;= 1 SPECIAL STUDIES; OCCULT BLOOD SCREEN, FECES OCBLD N/A HIGH NEGATIVE PRE-RX CHANGING TO POSITIVE</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate</measure>
    <time_frame>Days -3 to -1, Days 1, 5, 8, and 12.</time_frame>
    <description>Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate</measure>
    <time_frame>Days -3 to -1, Days 1, 5, 8, and 12.</time_frame>
    <description>Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate</measure>
    <time_frame>Days -3 to -1, Days 1, 5, 8, and 12.</time_frame>
    <description>Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate</measure>
    <time_frame>Days -3 to -1, Days 1, 5, 8, and 12.</time_frame>
    <description>Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate</measure>
    <time_frame>Days -3 to -1, Days 1, 5, 8, and 12</time_frame>
    <description>QTcF = QT corrected for heart rate using the Fridericia formula Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Change From Baseline in Vital Signs: Diastolic Blood Pressure</measure>
    <time_frame>Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)</measure>
    <time_frame>Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)</measure>
    <time_frame>Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameters of BMS-986177: Cmax</measure>
    <time_frame>Either Day 1, 5, 8, or 12 depending on the randomization sequence</time_frame>
    <description>Cmax: Maximum observed plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameters of BMS-986177: Tmax</measure>
    <time_frame>Either Day 1, 5, 8, or 12 depending on the randomization sequence</time_frame>
    <description>Time of maximum observed plasma concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24)</measure>
    <time_frame>Either Day 1, 5, 8, or 12 depending on the randomization sequence</time_frame>
    <description>AUC(0-T) Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-24) Area under the plasma concentration-time curve from time zero to 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameters of BMS-986177: fu</measure>
    <time_frame>Either Day 1, 5, 8, or 12 depending on the randomization sequence</time_frame>
    <description>Fraction of unbound drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameters of BMS-986177: Cmaxfu</measure>
    <time_frame>Either Day 1, 5, 8, or 12 depending on the randomization sequence</time_frame>
    <description>Maximum observed plasma concentration of free drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T)fu</measure>
    <time_frame>Either Day 1, 5, 8, or 12 depending on the randomization sequence</time_frame>
    <description>AUC(0-T)fu Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of free drug</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (3-7)</measure>
    <time_frame>Either Day 1, 5, 8, or 12 depending on the randomization sequence</time_frame>
    <description>AUC (3-7) : Area under the plasma concentration-time curve from 3 to 7 hours (ie, during dialysis.&#xD;
Determined from blood samples entering and exiting the dialyzer)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Antithrombotic</condition>
  <arm_group>
    <arm_group_label>Dose Sequence 1</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>UFH, BMS-986177 - dose 1, BMS-986177 - dose 2, Enoxaparin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Sequence 2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BMS-986177 - dose 1, Enoxaparin, UFH, BMS-986177 - dose 2</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Sequence 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BMS-986177 - dose 2, UFH, Enoxaparin, BMS-986177 - dose 1</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Sequence 4</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Enoxaparin, BMS-986177 - dose 2, BMS-986177 - dose 1, UFH</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Enoxaparin</intervention_name>
    <description>Specified dose of Enoxaparin on specified days</description>
    <arm_group_label>Dose Sequence 1</arm_group_label>
    <arm_group_label>Dose Sequence 2</arm_group_label>
    <arm_group_label>Dose Sequence 3</arm_group_label>
    <arm_group_label>Dose Sequence 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>unfractionated heparin (UFH)</intervention_name>
    <description>Specified dose of UFH on specified days</description>
    <arm_group_label>Dose Sequence 1</arm_group_label>
    <arm_group_label>Dose Sequence 2</arm_group_label>
    <arm_group_label>Dose Sequence 3</arm_group_label>
    <arm_group_label>Dose Sequence 4</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BMS-986177</intervention_name>
    <description>Specified dose of BMS-986177 on specified day</description>
    <arm_group_label>Dose Sequence 1</arm_group_label>
    <arm_group_label>Dose Sequence 2</arm_group_label>
    <arm_group_label>Dose Sequence 3</arm_group_label>
    <arm_group_label>Dose Sequence 4</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please&#xD;
        visit www.BMSStudyConnect.com&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with ESRD treated with hemodialysis 3 times a week for at least 3 months&#xD;
             prior enrollment.&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy&#xD;
             test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to&#xD;
             the start of study treatment.&#xD;
&#xD;
          -  Women must not be breastfeeding&#xD;
&#xD;
          -  Women of childbearing potential (WOCBP) must agree to follow instructions for&#xD;
             method(s) of contraception for the duration of treatment with study treatment(s)&#xD;
             BMS-986177 plus 5 half-lives of study treatment (2 days) plus 30 days (duration of&#xD;
             ovulatory cycle) for a total of 32 days post-treatment completion&#xD;
&#xD;
          -  Males who are sexually active with WOCBP must agree to follow instructions for&#xD;
             method(s) of contraception for the duration of treatment with study treatment(s)&#xD;
             BMS-986177 plus 5 half-lives of the study treatment plus 90 days (duration of sperm&#xD;
             turnover) for a total of 92 days post-treatment completion. In addition, male&#xD;
             participants must be willing to refrain from sperm donation during this time.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects receiving dialysis through central venous catheters&#xD;
&#xD;
          -  History of uncontrolled or unstable cardiovascular, respiratory, hepatic,&#xD;
             gastrointestinal, endocrine, hematopoietic, psychiatric and/or neurological disease in&#xD;
             the past 3 months&#xD;
&#xD;
          -  Current or recent (within 3 months of study drug administration) gastrointestinal&#xD;
             disease or surgery, which by the judgment of the Investigator, may increase a&#xD;
             subject's risk of gastrointestinal bleeding or interfere with absorption of study drug&#xD;
             (e.g., peptic or gastric ulcer disease, severe gastritis, history of gastrointestinal&#xD;
             surgery).&#xD;
&#xD;
          -  Any major surgery within 12 weeks of study drug administration&#xD;
&#xD;
          -  History of significant head injury within the last 2 years, including subjects with&#xD;
             base of skull fractures&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria could apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Davita Clinical Research</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Clinical Research Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Davita Clinical Research</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://bms.com/studyconnect/Pages/home.aspx</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <results_first_submitted>October 30, 2020</results_first_submitted>
  <results_first_submitted_qc>December 3, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 29, 2020</results_first_posted>
  <disposition_first_submitted>November 7, 2018</disposition_first_submitted>
  <disposition_first_submitted_qc>December 3, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">December 29, 2020</disposition_first_posted>
  <last_update_submitted>December 3, 2020</last_update_submitted>
  <last_update_submitted_qc>December 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heparin</mesh_term>
    <mesh_term>Enoxaparin</mesh_term>
    <mesh_term>Calcium heparin</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03000673/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 2, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/73/NCT03000673/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>32 participants were randomized and treated.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Sequence ABCD</title>
          <description>Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection</description>
        </group>
        <group group_id="P2">
          <title>Sequence BDAC</title>
          <description>Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection</description>
        </group>
        <group group_id="P3">
          <title>Sequence CADB</title>
          <description>Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection</description>
        </group>
        <group group_id="P4">
          <title>Sequence DCBA</title>
          <description>Treatments: A = UFH intravenous infusion; B = BMS-986177 100 mg; C = BMS-986177 300 mg; D = enoxaparin 40 mg by subcutaneous injection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="9"/>
                <participants group_id="P3" count="7"/>
                <participants group_id="P4" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Seq ABCD</title>
          <description>Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection</description>
        </group>
        <group group_id="B2">
          <title>Seq BDAC</title>
          <description>Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection.</description>
        </group>
        <group group_id="B3">
          <title>Seq CADB</title>
          <description>Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection</description>
        </group>
        <group group_id="B4">
          <title>Seq DCBA</title>
          <description>Treatments: A=UFH intravenous infusion; B=BMS-986177 100 mg; C=BMS-986177 300 mg; D=Enoxaparin 40 mg by subcutaneous injection.</description>
        </group>
        <group group_id="B5">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="7"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="7"/>
            <count group_id="B4" value="9"/>
            <count group_id="B5" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="55.1" spread="7.3"/>
                    <measurement group_id="B2" value="55.6" spread="6.6"/>
                    <measurement group_id="B3" value="52.0" spread="12.4"/>
                    <measurement group_id="B4" value="51.7" spread="9.9"/>
                    <measurement group_id="B5" value="53.6" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="3"/>
                    <measurement group_id="B5" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="6"/>
                    <measurement group_id="B5" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="9"/>
                    <measurement group_id="B5" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                    <measurement group_id="B5" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="8"/>
                    <measurement group_id="B5" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death</title>
        <description>Safety and tolerability of single oral doses of BMS-986177 in patients with end-stage renal disease (ESRD) on chronic hemodialysis (HD) treatment as measured by the number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation and death</description>
        <time_frame>From the date of patient's written consent to participate in study until 30 days after discontinuation of dosing or patient's participation in study (up to October 2017)</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
          <group group_id="O3">
            <title>Treatment D</title>
            <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
          </group>
          <group group_id="O4">
            <title>Treatment A</title>
            <description>Treatments: A = UFH intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death</title>
          <description>Safety and tolerability of single oral doses of BMS-986177 in patients with end-stage renal disease (ESRD) on chronic hemodialysis (HD) treatment as measured by the number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation and death</description>
          <population>All treated participants</population>
          <units>Participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Serious Adverse Events</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Adverse Events Leading to Discontinuations</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Deaths</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation</title>
        <description>HEMATOLOGY I; HEMOGLOBIN HB G/DL LOW &lt; 0.85*PRE-RX; HEMATOCRIT HCT % LOW &lt; 0.85*PRE-RX; PLATELET COUNT PLAT X10*9 C/L LOW &lt; 0.85*LLN IF PRE-RX IS MISSING; &lt; 0.85*LLN IF PRE-RX &gt;= LLN; &lt; 0.85*PRE-RX IF PRE-RX &lt; LLN; HIGH &gt; 1.5*ULN; HEMATOLOGY II; LEUKOCYTES WBC X10*3 C/UL LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF LLN &lt;= PRE-RX &lt;= ULN; &lt; 0.85*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.2*ULN IF PRE-RX IS MISSING; &gt; 1.2*ULN IF LLN &lt;= PRE-RX &lt;= ULN; &gt; 1.5*PRE-RX IF PRE-RX &gt; ULN; NEUTROPHILS (ABSOLUTE) NEUTA X10*3 C/UL LOW &lt; 1.5 IF PRE-RX IS MISSING; &lt; 1.5 IF PRE-RX &gt;= 1.5; &lt; 0.85*PRE-RX IF; PRE-RX &lt; 1.5; LYMPHOCYTES (ABSOLUTE) LYMPA X10*3 C/UL LOW &lt; 0.75; HIGH &gt; 7.5; MONOCYTES (ABSOLUTE) MONOA X10*3 C/UL HIGH &gt; 2; BASOPHILS (ABSOLUTE) BASOA X10*3 C/UL HIGH &gt; 0.4; EOSINOPHILS (ABSOLUTE) EOSA X10*3 C/UL HIGH &gt; 0.75; COAGULATION: PROTHROMBIN TIME (PT) PT SEC HIGH &gt; 1.5*ULN; APTT APTT SEC HIGH &gt; 1.5*ULN; INTL NORMALIZED RATIO (INR) INR FRACTION HIGH &gt; 1.5*ULN;</description>
        <time_frame>At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.</time_frame>
        <population>All treated participants with evaluable test results</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
          <group group_id="O3">
            <title>Treatment D</title>
            <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
          </group>
          <group group_id="O4">
            <title>Treatment A</title>
            <description>Treatments: A = UFH intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation</title>
          <description>HEMATOLOGY I; HEMOGLOBIN HB G/DL LOW &lt; 0.85*PRE-RX; HEMATOCRIT HCT % LOW &lt; 0.85*PRE-RX; PLATELET COUNT PLAT X10*9 C/L LOW &lt; 0.85*LLN IF PRE-RX IS MISSING; &lt; 0.85*LLN IF PRE-RX &gt;= LLN; &lt; 0.85*PRE-RX IF PRE-RX &lt; LLN; HIGH &gt; 1.5*ULN; HEMATOLOGY II; LEUKOCYTES WBC X10*3 C/UL LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF LLN &lt;= PRE-RX &lt;= ULN; &lt; 0.85*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.2*ULN IF PRE-RX IS MISSING; &gt; 1.2*ULN IF LLN &lt;= PRE-RX &lt;= ULN; &gt; 1.5*PRE-RX IF PRE-RX &gt; ULN; NEUTROPHILS (ABSOLUTE) NEUTA X10*3 C/UL LOW &lt; 1.5 IF PRE-RX IS MISSING; &lt; 1.5 IF PRE-RX &gt;= 1.5; &lt; 0.85*PRE-RX IF; PRE-RX &lt; 1.5; LYMPHOCYTES (ABSOLUTE) LYMPA X10*3 C/UL LOW &lt; 0.75; HIGH &gt; 7.5; MONOCYTES (ABSOLUTE) MONOA X10*3 C/UL HIGH &gt; 2; BASOPHILS (ABSOLUTE) BASOA X10*3 C/UL HIGH &gt; 0.4; EOSINOPHILS (ABSOLUTE) EOSA X10*3 C/UL HIGH &gt; 0.75; COAGULATION: PROTHROMBIN TIME (PT) PT SEC HIGH &gt; 1.5*ULN; APTT APTT SEC HIGH &gt; 1.5*ULN; INTL NORMALIZED RATIO (INR) INR FRACTION HIGH &gt; 1.5*ULN;</description>
          <population>All treated participants with evaluable test results</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Hematology I Hemoglobin (G/DL) Abnormal low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hematocrit (%) Abnormal low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Platelet Count (X10*9 C/L) Abnormal low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes (X10*3 C/UL) Abnormal low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Leukocytes (X10*3 C/UL): Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neutrophils (Absolute) (X10*3 C/UL)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lymphocytes (Absolute) (X10*3 C/UL) Abnormal low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Monocytes (Absolute) (X10*3 C/UL) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Basophils (Absolute) (X10*3 C/UL) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eosinophils (Absolute) (X10*3 C/UL)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prothrombin time (PT) (sec): Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APTT (sec): Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="25"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>APTT (sec): Not reported</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>INR (fraction): Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function</title>
        <description>LIVER &amp; KIDNEY FUNCTION; ALKALINE PHOSPHATASE (ALP) ALP U/L HIGH &gt; 1.25*ULN IF PRE-RX IS MISSING; &gt; 1.25*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L HIGH &gt; 1.25*ULN IF PRE-RX IS MISSING; &gt; 1.25*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L HIGH &gt; 1.25*ULN IF PRE-RX IS MISSING; &gt; 1.25*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; BILIRUBIN, TOTAL TBILI MG/DL HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; BILIRUBIN, DIRECT DBILI MG/DL HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; BLOOD UREA NITROGEN BUN MG/DL HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.2*PRE-RX IF PRE-RX &gt; ULN; CREATININE CREAT MG/DL HIGH &gt; 1.5*ULN IF PRE-RX IS MISSING; &gt; 1.5*ULN IF PRE-RX &lt;= ULN; &gt; 1.33*PRE-RX IF PRE-RX &gt; ULN;</description>
        <time_frame>At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.</time_frame>
        <population>All treated participants with evaluable test results</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
          <group group_id="O3">
            <title>Treatment D</title>
            <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
          </group>
          <group group_id="O4">
            <title>Treatment A</title>
            <description>Treatments: A = UFH intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function</title>
          <description>LIVER &amp; KIDNEY FUNCTION; ALKALINE PHOSPHATASE (ALP) ALP U/L HIGH &gt; 1.25*ULN IF PRE-RX IS MISSING; &gt; 1.25*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L HIGH &gt; 1.25*ULN IF PRE-RX IS MISSING; &gt; 1.25*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L HIGH &gt; 1.25*ULN IF PRE-RX IS MISSING; &gt; 1.25*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; BILIRUBIN, TOTAL TBILI MG/DL HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; BILIRUBIN, DIRECT DBILI MG/DL HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; BLOOD UREA NITROGEN BUN MG/DL HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.2*PRE-RX IF PRE-RX &gt; ULN; CREATININE CREAT MG/DL HIGH &gt; 1.5*ULN IF PRE-RX IS MISSING; &gt; 1.5*ULN IF PRE-RX &lt;= ULN; &gt; 1.33*PRE-RX IF PRE-RX &gt; ULN;</description>
          <population>All treated participants with evaluable test results</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>ALP (U/L) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST (U/L) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AST (U/L) Not reported</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ALT (U/L) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin, Total (MG/DL) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin, Direct (MG/DL) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bilirubin, Direct (MG/DL), Not reported</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Blood Urea Nitrogen (MG/DL) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine (MG/DL) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatinine (MG/DL) Not reported</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="31"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes</title>
        <description>ELECTROLYTES: SODIUM, SERUM NA MEQ/L LOW &lt; 0.95*LLN IF PRE-RX IS MISSING; &lt; 0.95*LLN IF PRE-RX &gt;= LLN; &lt; 0.95*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.05*ULN IF PRE-RX IS MISSING; &gt; 1.05*ULN IF PRE-RX &lt;= ULN; &gt; 1.05*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; POTASSIUM, SERUM K MEQ/L LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.1*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; CHLORIDE, SERUM CL MEQ/L LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.1*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN;</description>
        <time_frame>At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge</time_frame>
        <population>All treated participants with evaluable test results</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
          <group group_id="O3">
            <title>Treatment D</title>
            <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
          </group>
          <group group_id="O4">
            <title>Treatment A</title>
            <description>Treatments: A = UFH intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes</title>
          <description>ELECTROLYTES: SODIUM, SERUM NA MEQ/L LOW &lt; 0.95*LLN IF PRE-RX IS MISSING; &lt; 0.95*LLN IF PRE-RX &gt;= LLN; &lt; 0.95*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.05*ULN IF PRE-RX IS MISSING; &gt; 1.05*ULN IF PRE-RX &lt;= ULN; &gt; 1.05*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; POTASSIUM, SERUM K MEQ/L LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.1*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; CHLORIDE, SERUM CL MEQ/L LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.1*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN;</description>
          <population>All treated participants with evaluable test results</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sodium, Serum (MEQ/L), Abnormal low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Sodium, Serum (MEQ/L), Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, Serum (MEQ/L), Abnormal low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, Serum (MEQ/L), Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Potassium, Serum (MEQ/L), Not reported</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride, Serum (MEQ/L) Abnormal low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride, Serum (MEQ/L) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Chloride, Serum (MEQ/L) Not reported</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)</title>
        <description>ELECTROLYTES (CONT.): CALCIUM, TOTAL CA MG/DL LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.1*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; PHOSPHORUS, INORGANIC PHOS MG/DL LOW &lt; 0.85*LLN IF PRE-RX IS MISSING; &lt; 0.85*LLN IF PRE-RX &gt;= LLN; &lt; 0.85*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.25*ULN IF PRE-RX IS MISSING; &gt; 1.25*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; MAGNESIUM, SERUM MG MEQ/L LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.1*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN</description>
        <time_frame>At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.</time_frame>
        <population>All treated participants with evaluable test results</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
          <group group_id="O3">
            <title>Treatment D</title>
            <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
          </group>
          <group group_id="O4">
            <title>Treatment A</title>
            <description>Treatments: A = UFH intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)</title>
          <description>ELECTROLYTES (CONT.): CALCIUM, TOTAL CA MG/DL LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.1*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; PHOSPHORUS, INORGANIC PHOS MG/DL LOW &lt; 0.85*LLN IF PRE-RX IS MISSING; &lt; 0.85*LLN IF PRE-RX &gt;= LLN; &lt; 0.85*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.25*ULN IF PRE-RX IS MISSING; &gt; 1.25*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; MAGNESIUM, SERUM MG MEQ/L LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.1*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN</description>
          <population>All treated participants with evaluable test results</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Calcium, Total (MG/DL) Abnormal low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcium, Total (MG/DL) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphorus, Inorganic (MG/DL) Abnormal low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Phosphorus, Inorganic (MG/DL) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Magnesium, Serum (MEQ/L), Abnormal low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Magnesium, Serum (MEQ/L), Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Magnesium, Serum (MEQ/L), Not reported</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing</title>
        <description>GLUCOSE, FASTING SERUM GLUCF MG/DL LOW &lt; 0.8*LLN IF PRE-RX IS MISSING; &lt; 0.8*LLN IF PRE-RX &gt;= LLN; &lt; 0.8*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.3*ULN IF PRE-RX IS MISSING &gt; 1.3*ULN IF PRE-RX &lt;= ULN; &gt; 2*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; PROTEIN, TOTAL TPRO G/DL LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.1*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; ALBUMIN ALB G/DL LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; CREATINE KINASE (CK) CK U/L HIGH &gt; 1.5*ULN IF PRE-RX IS MISSING; &gt; 1.5*ULN IF PRE-RX &lt;= ULN; &gt; 1.5*PRE-RX IF PRE-RX &gt; ULN; URIC ACID URIC MG/DL HIGH &gt; 1.2*ULN IF PRE-RX IS MISSING; &gt; 1.2*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; LACTATE DEHYDR (LD) LD U/L HIGH &gt; 1.25*ULN IF PRE-RX IS MISSING; &gt; 1.25*ULN IF PRE-RX &lt;= ULN; &gt; 1.5*PRE-RX IF PRE-RX &gt; ULN</description>
        <time_frame>At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.</time_frame>
        <population>All treated participants with evaluable test results</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
          <group group_id="O3">
            <title>Treatment D</title>
            <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
          </group>
          <group group_id="O4">
            <title>Treatment A</title>
            <description>Treatments: A = UFH intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing</title>
          <description>GLUCOSE, FASTING SERUM GLUCF MG/DL LOW &lt; 0.8*LLN IF PRE-RX IS MISSING; &lt; 0.8*LLN IF PRE-RX &gt;= LLN; &lt; 0.8*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN; HIGH &gt; 1.3*ULN IF PRE-RX IS MISSING &gt; 1.3*ULN IF PRE-RX &lt;= ULN; &gt; 2*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; PROTEIN, TOTAL TPRO G/DL LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; &lt; LLN IF PRE-RX &gt; ULN HIGH &gt; 1.1*ULN IF PRE-RX IS MISSING; &gt; 1.1*ULN IF PRE-RX &lt;= ULN; &gt; 1.1*PRE-RX IF PRE-RX &gt; ULN; &gt; ULN IF PRE-RX &lt; LLN; ALBUMIN ALB G/DL LOW &lt; 0.9*LLN IF PRE-RX IS MISSING; &lt; 0.9*LLN IF PRE-RX &gt;= LLN; &lt; 0.9*PRE-RX IF PRE-RX &lt; LLN; CREATINE KINASE (CK) CK U/L HIGH &gt; 1.5*ULN IF PRE-RX IS MISSING; &gt; 1.5*ULN IF PRE-RX &lt;= ULN; &gt; 1.5*PRE-RX IF PRE-RX &gt; ULN; URIC ACID URIC MG/DL HIGH &gt; 1.2*ULN IF PRE-RX IS MISSING; &gt; 1.2*ULN IF PRE-RX &lt;= ULN; &gt; 1.25*PRE-RX IF PRE-RX &gt; ULN; LACTATE DEHYDR (LD) LD U/L HIGH &gt; 1.25*ULN IF PRE-RX IS MISSING; &gt; 1.25*ULN IF PRE-RX &lt;= ULN; &gt; 1.5*PRE-RX IF PRE-RX &gt; ULN</description>
          <population>All treated participants with evaluable test results</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Glucose, Fasting serum (MG/DL) Abnormal low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Glucose, Fasting serum (MG/DL) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="4"/>
                    <measurement group_id="O4" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Total (G/DL) Abnormal low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Protein, Total (G/DL) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Albumin (G/DL) Abnormal low</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase (CK) (U/L) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Creatine Kinase (CK) (U/L) Not reported</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Uric Acid (MG/DL) Abnormal High</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LD (U/L) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="3"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>LD (U/L) Not reported</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies</title>
        <description>URINALYSIS I; BLOOD, URINE UBLD N/A HIGH &gt;= 2 IF PRE-RX IS MISSING; &gt;= 2 IF PRE-RX &lt; 1; &gt;= 2 IF PRE-RX &gt;= 1 SPECIAL STUDIES; OCCULT BLOOD SCREEN, FECES OCBLD N/A HIGH NEGATIVE PRE-RX CHANGING TO POSITIVE</description>
        <time_frame>At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.</time_frame>
        <population>All treated participants with evaluable test results</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
          <group group_id="O3">
            <title>Treatment D</title>
            <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
          </group>
          <group group_id="O4">
            <title>Treatment A</title>
            <description>Treatments: A = UFH intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies</title>
          <description>URINALYSIS I; BLOOD, URINE UBLD N/A HIGH &gt;= 2 IF PRE-RX IS MISSING; &gt;= 2 IF PRE-RX &lt; 1; &gt;= 2 IF PRE-RX &gt;= 1 SPECIAL STUDIES; OCCULT BLOOD SCREEN, FECES OCBLD N/A HIGH NEGATIVE PRE-RX CHANGING TO POSITIVE</description>
          <population>All treated participants with evaluable test results</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Blood, Urine (N/A) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="8"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="6"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Occult Blood Screen, Feces (N/A) Abnormal high</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="21"/>
                    <count group_id="O2" value="18"/>
                    <count group_id="O3" value="15"/>
                    <count group_id="O4" value="19"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                    <measurement group_id="O4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate</title>
        <description>Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.</description>
        <time_frame>Days -3 to -1, Days 1, 5, 8, and 12.</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
          <group group_id="O3">
            <title>Treatment D</title>
            <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
          </group>
          <group group_id="O4">
            <title>Treatment A</title>
            <description>Treatments: A = UFH intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate</title>
          <description>Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.</description>
          <population>All treated participants</population>
          <units>Beats/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="8.6"/>
                    <measurement group_id="O2" value="1.4" spread="5.1"/>
                    <measurement group_id="O3" value="0.4" spread="8.1"/>
                    <measurement group_id="O4" value="-0.1" spread="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.1" spread="6.9"/>
                    <measurement group_id="O2" value="2.0" spread="10.8"/>
                    <measurement group_id="O3" value="2.0" spread="8.1"/>
                    <measurement group_id="O4" value="1.6" spread="5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.0" spread="6.9"/>
                    <measurement group_id="O2" value="-2.8" spread="6.1"/>
                    <measurement group_id="O3" value="2.3" spread="4.7"/>
                    <measurement group_id="O4" value="4.0" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="6.0"/>
                    <measurement group_id="O2" value="3.9" spread="9.5"/>
                    <measurement group_id="O3" value="0.8" spread="2.9"/>
                    <measurement group_id="O4" value="1.4" spread="9.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate</title>
        <description>Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.</description>
        <time_frame>Days -3 to -1, Days 1, 5, 8, and 12.</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
          <group group_id="O3">
            <title>Treatment D</title>
            <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
          </group>
          <group group_id="O4">
            <title>Treatment A</title>
            <description>Treatments: A = UFH intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate</title>
          <description>Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.</description>
          <population>All treated participants</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="9.9"/>
                    <measurement group_id="O2" value="-25.0" spread="67.8"/>
                    <measurement group_id="O3" value="-6.9" spread="12.6"/>
                    <measurement group_id="O4" value="13.6" spread="26.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.6" spread="21.2"/>
                    <measurement group_id="O2" value="-5.8" spread="8.9"/>
                    <measurement group_id="O3" value="-5.1" spread="11.8"/>
                    <measurement group_id="O4" value="-25.4" spread="66.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="19.3"/>
                    <measurement group_id="O2" value="12.7" spread="25.5"/>
                    <measurement group_id="O3" value="-22.6" spread="70.3"/>
                    <measurement group_id="O4" value="-3.4" spread="27.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-27.7" spread="67.9"/>
                    <measurement group_id="O2" value="-5.6" spread="8.7"/>
                    <measurement group_id="O3" value="8.8" spread="12.4"/>
                    <measurement group_id="O4" value="-2.6" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate</title>
        <description>Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.</description>
        <time_frame>Days -3 to -1, Days 1, 5, 8, and 12.</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
          <group group_id="O3">
            <title>Treatment D</title>
            <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
          </group>
          <group group_id="O4">
            <title>Treatment A</title>
            <description>Treatments: A = UFH intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate</title>
          <description>Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.</description>
          <population>All treated participants</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.1" spread="6.7"/>
                    <measurement group_id="O2" value="5.7" spread="6.2"/>
                    <measurement group_id="O3" value="-0.2" spread="3.3"/>
                    <measurement group_id="O4" value="-3.1" spread="11.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.3" spread="14.8"/>
                    <measurement group_id="O2" value="-0.2" spread="4.6"/>
                    <measurement group_id="O3" value="-0.2" spread="4.6"/>
                    <measurement group_id="O4" value="0.6" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.2" spread="4.2"/>
                    <measurement group_id="O2" value="-1.8" spread="8.8"/>
                    <measurement group_id="O3" value="-0.7" spread="6.0"/>
                    <measurement group_id="O4" value="0.3" spread="8.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9" spread="6.3"/>
                    <measurement group_id="O2" value="-0.1" spread="9.3"/>
                    <measurement group_id="O3" value="-0.7" spread="9.7"/>
                    <measurement group_id="O4" value="2.0" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate</title>
        <description>Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.</description>
        <time_frame>Days -3 to -1, Days 1, 5, 8, and 12.</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
          <group group_id="O3">
            <title>Treatment D</title>
            <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
          </group>
          <group group_id="O4">
            <title>Treatment A</title>
            <description>Treatments: A = UFH intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate</title>
          <description>Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.</description>
          <population>All treated participants</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.7" spread="22.2"/>
                    <measurement group_id="O2" value="-1.6" spread="20.8"/>
                    <measurement group_id="O3" value="-3.1" spread="24.0"/>
                    <measurement group_id="O4" value="3.9" spread="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4" spread="19.3"/>
                    <measurement group_id="O2" value="-7.4" spread="20.1"/>
                    <measurement group_id="O3" value="-2.8" spread="22.0"/>
                    <measurement group_id="O4" value="5.6" spread="15.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.8" spread="21.3"/>
                    <measurement group_id="O2" value="12.0" spread="11.9"/>
                    <measurement group_id="O3" value="-3.6" spread="24.0"/>
                    <measurement group_id="O4" value="-7.4" spread="26.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7" spread="20.1"/>
                    <measurement group_id="O2" value="-14.9" spread="28.2"/>
                    <measurement group_id="O3" value="-0.7" spread="10.8"/>
                    <measurement group_id="O4" value="-2.2" spread="20.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate</title>
        <description>QTcF = QT corrected for heart rate using the Fridericia formula Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.</description>
        <time_frame>Days -3 to -1, Days 1, 5, 8, and 12</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
          <group group_id="O3">
            <title>Treatment D</title>
            <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
          </group>
          <group group_id="O4">
            <title>Treatment A</title>
            <description>Treatments: A = UFH intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate</title>
          <description>QTcF = QT corrected for heart rate using the Fridericia formula Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.</description>
          <population>All treated participants</population>
          <units>msec</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Day 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="7"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.2" spread="15.3"/>
                    <measurement group_id="O2" value="1.7" spread="13.5"/>
                    <measurement group_id="O3" value="-1.0" spread="16.5"/>
                    <measurement group_id="O4" value="5.7" spread="15.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="9"/>
                    <count group_id="O4" value="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="7.6"/>
                    <measurement group_id="O2" value="-4.9" spread="11.8"/>
                    <measurement group_id="O3" value="-0.6" spread="13.1"/>
                    <measurement group_id="O4" value="9.9" spread="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 8</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="9"/>
                    <count group_id="O2" value="6"/>
                    <count group_id="O3" value="7"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.3" spread="17.1"/>
                    <measurement group_id="O2" value="6.2" spread="6.7"/>
                    <measurement group_id="O3" value="0.3" spread="19.7"/>
                    <measurement group_id="O4" value="-2.1" spread="18.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 12</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="7"/>
                    <count group_id="O2" value="9"/>
                    <count group_id="O3" value="6"/>
                    <count group_id="O4" value="9"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.1" spread="15.0"/>
                    <measurement group_id="O2" value="-9.9" spread="22.8"/>
                    <measurement group_id="O3" value="0.8" spread="7.1"/>
                    <measurement group_id="O4" value="1.0" spread="10.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Change From Baseline in Vital Signs: Diastolic Blood Pressure</title>
        <time_frame>Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
          <group group_id="O3">
            <title>Treatment D</title>
            <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
          </group>
          <group group_id="O4">
            <title>Treatment A</title>
            <description>Treatments: A = UFH intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline in Vital Signs: Diastolic Blood Pressure</title>
          <population>All treated participants</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 hours post Hemodialysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.7" spread="10.5"/>
                    <measurement group_id="O2" value="0.2" spread="10.9"/>
                    <measurement group_id="O3" value="0.1" spread="9.0"/>
                    <measurement group_id="O4" value="0.5" spread="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours post dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.8" spread="9.9"/>
                    <measurement group_id="O2" value="-2.2" spread="8.7"/>
                    <measurement group_id="O3" value="NA" spread="NA">No dose of BMS-986177, as Treatment D was Enoxaparin 40 mg by subcutaneous injection</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">No dose of BMS-986177, as Treatment A was UFH intravenous infusion</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)</title>
        <time_frame>Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
          <group group_id="O3">
            <title>Treatment D</title>
            <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
          </group>
          <group group_id="O4">
            <title>Treatment A</title>
            <description>Treatments: A = UFH intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)</title>
          <population>All treated participants</population>
          <units>mmHg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 hours post hemodialysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="31"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-6.6" spread="28.2"/>
                    <measurement group_id="O2" value="1.1" spread="24.9"/>
                    <measurement group_id="O3" value="-0.2" spread="17.0"/>
                    <measurement group_id="O4" value="-5.8" spread="18.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours post dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.4" spread="23.7"/>
                    <measurement group_id="O2" value="-9.2" spread="17.6"/>
                    <measurement group_id="O3" value="NA" spread="NA">No dose of BMS-986177 as Treatment D was Enoxaparin 40 mg by subcutaneous injection</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">No dose of BMS-986177, as Treatment A was UFH intravenous infusion</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic Parameters of BMS-986177: Cmax</title>
        <description>Cmax: Maximum observed plasma concentration</description>
        <time_frame>Either Day 1, 5, 8, or 12 depending on the randomization sequence</time_frame>
        <population>All treated and evaluable participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameters of BMS-986177: Cmax</title>
          <description>Cmax: Maximum observed plasma concentration</description>
          <population>All treated and evaluable participants</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1120" spread="391.8"/>
                    <measurement group_id="O2" value="3342" spread="922.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)</title>
        <time_frame>Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15</time_frame>
        <population>All treated participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
          <group group_id="O3">
            <title>Treatment D</title>
            <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
          </group>
          <group group_id="O4">
            <title>Treatment A</title>
            <description>Treatment A = UFH intravenous infusion</description>
          </group>
        </group_list>
        <measure>
          <title>The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)</title>
          <population>All treated participants</population>
          <units>beats/min</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
                <count group_id="O3" value="31"/>
                <count group_id="O4" value="32"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>3 hours post hemodialysis</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="30"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="9.4"/>
                    <measurement group_id="O2" value="4.0" spread="7.4"/>
                    <measurement group_id="O3" value="4.5" spread="6.5"/>
                    <measurement group_id="O4" value="3.3" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>24 hours post dose</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="30"/>
                    <count group_id="O3" value="31"/>
                    <count group_id="O4" value="32"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.2" spread="5.6"/>
                    <measurement group_id="O2" value="1.1" spread="7.0"/>
                    <measurement group_id="O3" value="NA" spread="NA">No dose of BMS-986177 as Treatment D was Enoxaparin 40 mg by subcutaneous injection</measurement>
                    <measurement group_id="O4" value="NA" spread="NA">No dose of BMS-986177, as Treatment A was UFH intravenous infusion</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic Parameters of BMS-986177: Tmax</title>
        <description>Time of maximum observed plasma concentration</description>
        <time_frame>Either Day 1, 5, 8, or 12 depending on the randomization sequence</time_frame>
        <population>All treated and evaluable participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameters of BMS-986177: Tmax</title>
          <description>Time of maximum observed plasma concentration</description>
          <population>All treated and evaluable participants</population>
          <units>h</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.531" spread="0.933"/>
                    <measurement group_id="O2" value="4.855" spread="1.042"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24)</title>
        <description>AUC(0-T) Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-24) Area under the plasma concentration-time curve from time zero to 24 hours</description>
        <time_frame>Either Day 1, 5, 8, or 12 depending on the randomization sequence</time_frame>
        <population>All treated and evaluable participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24)</title>
          <description>AUC(0-T) Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-24) Area under the plasma concentration-time curve from time zero to 24 hours</description>
          <population>All treated and evaluable participants</population>
          <units>ng.h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AUC (0-T)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="32"/>
                    <count group_id="O2" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10406.6" spread="4551.7"/>
                    <measurement group_id="O2" value="36112.9" spread="19802.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>AUC (0-24)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="30"/>
                    <count group_id="O2" value="31"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10533.4" spread="4492.8"/>
                    <measurement group_id="O2" value="34028.0" spread="12191.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic Parameters of BMS-986177: fu</title>
        <description>Fraction of unbound drug</description>
        <time_frame>Either Day 1, 5, 8, or 12 depending on the randomization sequence</time_frame>
        <population>All treated and evaluable participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameters of BMS-986177: fu</title>
          <description>Fraction of unbound drug</description>
          <population>All treated and evaluable participants</population>
          <units>Percentage</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.644" spread="1.257"/>
                    <measurement group_id="O2" value="7.868" spread="1.481"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic Parameters of BMS-986177: Cmaxfu</title>
        <description>Maximum observed plasma concentration of free drug</description>
        <time_frame>Either Day 1, 5, 8, or 12 depending on the randomization sequence</time_frame>
        <population>All treated and evaluable participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameters of BMS-986177: Cmaxfu</title>
          <description>Maximum observed plasma concentration of free drug</description>
          <population>All treated and evaluable participants</population>
          <units>ng/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="84.32" spread="30.14"/>
                    <measurement group_id="O2" value="257.9" spread="70.40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T)fu</title>
        <description>AUC(0-T)fu Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of free drug</description>
        <time_frame>Either Day 1, 5, 8, or 12 depending on the randomization sequence</time_frame>
        <population>All treated and evaluable participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T)fu</title>
          <description>AUC(0-T)fu Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of free drug</description>
          <population>All treated and evaluable participants</population>
          <units>ng.h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="783.5" spread="342.1"/>
                    <measurement group_id="O2" value="2782.2" spread="1537.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (3-7)</title>
        <description>AUC (3-7) : Area under the plasma concentration-time curve from 3 to 7 hours (ie, during dialysis.&#xD;
Determined from blood samples entering and exiting the dialyzer)</description>
        <time_frame>Either Day 1, 5, 8, or 12 depending on the randomization sequence</time_frame>
        <population>All treated and evaluable participants</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment B</title>
            <description>Treatment B = BMS-986177 100 mg oral suspension</description>
          </group>
          <group group_id="O2">
            <title>Treatment C</title>
            <description>Treatment C = BMS-986177 300 mg oral suspension</description>
          </group>
        </group_list>
        <measure>
          <title>Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (3-7)</title>
          <description>AUC (3-7) : Area under the plasma concentration-time curve from 3 to 7 hours (ie, during dialysis.&#xD;
Determined from blood samples entering and exiting the dialyzer)</description>
          <population>All treated and evaluable participants</population>
          <units>ng.h/mL</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="32"/>
                <count group_id="O2" value="31"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2847.4" spread="1039.1"/>
                    <measurement group_id="O2" value="8558.1" spread="2509.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the date of the patient's written consent to participate in the study until 30 days after discontinuation of dosing</time_frame>
      <desc>The collection of nonserious AE information began 3 hours prior to dialysis start on Day 1, and continued until the follow-up contact</desc>
      <group_list>
        <group group_id="E1">
          <title>Treatment A</title>
          <description>Treatment A = UFH intravenous infusion;</description>
        </group>
        <group group_id="E2">
          <title>Treatment B</title>
          <description>Treatment B = BMS-986177 100 mg</description>
        </group>
        <group group_id="E3">
          <title>Treatment C</title>
          <description>Treatment C = BMS-986177 300 mg</description>
        </group>
        <group group_id="E4">
          <title>Treatment D</title>
          <description>Treatment D = enoxaparin 40 mg by subcutaneous injection</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="32"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="31"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Bristol-Myers Squibb Study Director</name_or_title>
      <organization>Bristol-Myers Squibb</organization>
      <phone>Please email</phone>
      <email>Clinical.Trials@bms.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03000673
org study id: CV010-010
nct id: NCT03000673
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To investigate safety of Single Doses of BMS-986177 in Patients with End Stage Renal Disease
      treated with hemodialysis
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The Number of Adverse Events (AEs), Serious AEs (SAEs), AEs Leading to Discontinuation and Death
time frame: From the date of patient's written consent to participate in study until 30 days after discontinuation of dosing or patient's participation in study (up to October 2017)
description: Safety and tolerability of single oral doses of BMS-986177 in patients with end-stage renal disease (ESRD) on chronic hemodialysis (HD) treatment as measured by the number of participants with adverse events (AEs), serious AEs (SAEs), AEs leading to discontinuation and death
measure: The Number of Participants Marked Abnormalities in Clinical Laboratory Tests : Hematology I; Hematology II; Coagulation
time frame: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.
description: HEMATOLOGY I; HEMOGLOBIN HB G/DL LOW < 0.85*PRE-RX; HEMATOCRIT HCT % LOW < 0.85*PRE-RX; PLATELET COUNT PLAT X10*9 C/L LOW < 0.85*LLN IF PRE-RX IS MISSING; < 0.85*LLN IF PRE-RX >= LLN; < 0.85*PRE-RX IF PRE-RX < LLN; HIGH > 1.5*ULN; HEMATOLOGY II; LEUKOCYTES WBC X10*3 C/UL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF LLN <= PRE-RX <= ULN; < 0.85*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.2*ULN IF PRE-RX IS MISSING; > 1.2*ULN IF LLN <= PRE-RX <= ULN; > 1.5*PRE-RX IF PRE-RX > ULN; NEUTROPHILS (ABSOLUTE) NEUTA X10*3 C/UL LOW < 1.5 IF PRE-RX IS MISSING; < 1.5 IF PRE-RX >= 1.5; < 0.85*PRE-RX IF; PRE-RX < 1.5; LYMPHOCYTES (ABSOLUTE) LYMPA X10*3 C/UL LOW < 0.75; HIGH > 7.5; MONOCYTES (ABSOLUTE) MONOA X10*3 C/UL HIGH > 2; BASOPHILS (ABSOLUTE) BASOA X10*3 C/UL HIGH > 0.4; EOSINOPHILS (ABSOLUTE) EOSA X10*3 C/UL HIGH > 0.75; COAGULATION: PROTHROMBIN TIME (PT) PT SEC HIGH > 1.5*ULN; APTT APTT SEC HIGH > 1.5*ULN; INTL NORMALIZED RATIO (INR) INR FRACTION HIGH > 1.5*ULN;
measure: The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Liver and Kidney Function
time frame: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.
description: LIVER & KIDNEY FUNCTION; ALKALINE PHOSPHATASE (ALP) ALP U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; ASPARTATE AMINOTRANSFERASE (AST) AST U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; ALANINE AMINOTRANSFERASE (ALT) ALT U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; BILIRUBIN, TOTAL TBILI MG/DL HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; BILIRUBIN, DIRECT DBILI MG/DL HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; BLOOD UREA NITROGEN BUN MG/DL HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.2*PRE-RX IF PRE-RX > ULN; CREATININE CREAT MG/DL HIGH > 1.5*ULN IF PRE-RX IS MISSING; > 1.5*ULN IF PRE-RX <= ULN; > 1.33*PRE-RX IF PRE-RX > ULN;
measure: The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes
time frame: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge
description: ELECTROLYTES: SODIUM, SERUM NA MEQ/L LOW < 0.95*LLN IF PRE-RX IS MISSING; < 0.95*LLN IF PRE-RX >= LLN; < 0.95*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.05*ULN IF PRE-RX IS MISSING; > 1.05*ULN IF PRE-RX <= ULN; > 1.05*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; POTASSIUM, SERUM K MEQ/L LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; CHLORIDE, SERUM CL MEQ/L LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN;
measure: The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Electrolytes (Cont.)
time frame: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.
description: ELECTROLYTES (CONT.): CALCIUM, TOTAL CA MG/DL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; PHOSPHORUS, INORGANIC PHOS MG/DL LOW < 0.85*LLN IF PRE-RX IS MISSING; < 0.85*LLN IF PRE-RX >= LLN; < 0.85*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; MAGNESIUM, SERUM MG MEQ/L LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN
measure: The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.): Other Chemistry Testing
time frame: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.
description: GLUCOSE, FASTING SERUM GLUCF MG/DL LOW < 0.8*LLN IF PRE-RX IS MISSING; < 0.8*LLN IF PRE-RX >= LLN; < 0.8*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN; HIGH > 1.3*ULN IF PRE-RX IS MISSING > 1.3*ULN IF PRE-RX <= ULN; > 2*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; PROTEIN, TOTAL TPRO G/DL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; < LLN IF PRE-RX > ULN HIGH > 1.1*ULN IF PRE-RX IS MISSING; > 1.1*ULN IF PRE-RX <= ULN; > 1.1*PRE-RX IF PRE-RX > ULN; > ULN IF PRE-RX < LLN; ALBUMIN ALB G/DL LOW < 0.9*LLN IF PRE-RX IS MISSING; < 0.9*LLN IF PRE-RX >= LLN; < 0.9*PRE-RX IF PRE-RX < LLN; CREATINE KINASE (CK) CK U/L HIGH > 1.5*ULN IF PRE-RX IS MISSING; > 1.5*ULN IF PRE-RX <= ULN; > 1.5*PRE-RX IF PRE-RX > ULN; URIC ACID URIC MG/DL HIGH > 1.2*ULN IF PRE-RX IS MISSING; > 1.2*ULN IF PRE-RX <= ULN; > 1.25*PRE-RX IF PRE-RX > ULN; LACTATE DEHYDR (LD) LD U/L HIGH > 1.25*ULN IF PRE-RX IS MISSING; > 1.25*ULN IF PRE-RX <= ULN; > 1.5*PRE-RX IF PRE-RX > ULN
measure: The Number of Marked Abnormalities in Clinical Laboratory Tests (Cont.) : Urinalysis I, Special Studies
time frame: At screening; On Day -3 to Day -1, 3 to 6 hours post HD on Days 1, 5, 8, and 12; and at study discharge.
description: URINALYSIS I; BLOOD, URINE UBLD N/A HIGH >= 2 IF PRE-RX IS MISSING; >= 2 IF PRE-RX < 1; >= 2 IF PRE-RX >= 1 SPECIAL STUDIES; OCCULT BLOOD SCREEN, FECES OCBLD N/A HIGH NEGATIVE PRE-RX CHANGING TO POSITIVE
measure: The Change From Baseline in Electrocardiogram (ECG) Parameters: Mean Heart Rate
time frame: Days -3 to -1, Days 1, 5, 8, and 12.
description: Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
measure: The Change From Baseline in Electrocardiogram (ECG) Parameters: PR Interval, Aggregate
time frame: Days -3 to -1, Days 1, 5, 8, and 12.
description: Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
measure: The Change From Baseline in Electrocardiogram (ECG) Parameters: QRS Duration, Aggregate
time frame: Days -3 to -1, Days 1, 5, 8, and 12.
description: Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
measure: The Change From Baseline in Electrocardiogram (ECG) Parameters: QT Interval, Aggregate
time frame: Days -3 to -1, Days 1, 5, 8, and 12.
description: Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
measure: The Change From Baseline in Electrocardiogram (ECG) Parameters: QTcF Interval, Aggregate
time frame: Days -3 to -1, Days 1, 5, 8, and 12
description: QTcF = QT corrected for heart rate using the Fridericia formula Baseline = Last non-missing result with a collection date-time less than the date-time of the first active dose of study medication.
measure: The Change From Baseline in Vital Signs: Diastolic Blood Pressure
time frame: Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15
measure: The Change From Baseline in Vital Signs: Systolic Blood Pressure (mm Hg)
time frame: Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15
measure: The Change From Baseline in Vital Signs: Heart Rate (Beats/Min)
time frame: Days -3 to -1, 1, 5, 8, 12 and at study discharge on day 13 to day 15
measure: Pharmacokinetic Parameters of BMS-986177: Cmax
time frame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
description: Cmax: Maximum observed plasma concentration
measure: Pharmacokinetic Parameters of BMS-986177: Tmax
time frame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
description: Time of maximum observed plasma concentration
measure: Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T), AUC (0-24)
time frame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
description: AUC(0-T) Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration AUC(0-24) Area under the plasma concentration-time curve from time zero to 24 hours
measure: Pharmacokinetic Parameters of BMS-986177: fu
time frame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
description: Fraction of unbound drug
measure: Pharmacokinetic Parameters of BMS-986177: Cmaxfu
time frame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
description: Maximum observed plasma concentration of free drug
measure: Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (0-T)fu
time frame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
description: AUC(0-T)fu Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration of free drug
measure: Pharmacokinetic Parameters of BMS-986177: Area Under the Concentration Curve AUC (3-7)
time frame: Either Day 1, 5, 8, or 12 depending on the randomization sequence
description: AUC (3-7) : Area under the plasma concentration-time curve from 3 to 7 hours (ie, during dialysis.
Determined from blood samples entering and exiting the dialyzer)
arm group label: Dose Sequence 1
arm group type: Active Comparator
description: UFH, BMS-986177 - dose 1, BMS-986177 - dose 2, Enoxaparin
arm group label: Dose Sequence 2
arm group type: Active Comparator
description: BMS-986177 - dose 1, Enoxaparin, UFH, BMS-986177 - dose 2
arm group label: Dose Sequence 3
arm group type: Active Comparator
description: BMS-986177 - dose 2, UFH, Enoxaparin, BMS-986177 - dose 1
arm group label: Dose Sequence 4
arm group type: Active Comparator
description: Enoxaparin, BMS-986177 - dose 2, BMS-986177 - dose 1, UFH
intervention type: Drug
intervention name: Enoxaparin
description: Specified dose of Enoxaparin on specified days
arm group label: Dose Sequence 1
arm group label: Dose Sequence 2
arm group label: Dose Sequence 3
arm group label: Dose Sequence 4
intervention type: Drug
intervention name: unfractionated heparin (UFH)
description: Specified dose of UFH on specified days
arm group label: Dose Sequence 1
arm group label: Dose Sequence 2
arm group label: Dose Sequence 3
arm group label: Dose Sequence 4
intervention type: Drug
intervention name: BMS-986177
description: Specified dose of BMS-986177 on specified day
arm group label: Dose Sequence 1
arm group label: Dose Sequence 2
arm group label: Dose Sequence 3
arm group label: Dose Sequence 4
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
facility: 
facility: 
facility: 
country: United States
url: http://bms.com/studyconnect/Pages/home.aspx
description: BMS Clinical Trial Patient Recruiting
responsible party type: Sponsor
mesh term: Heparin
mesh term: Enoxaparin
mesh term: Calcium heparin
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 