<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/NCT02205905</url>
  </required_header>
  <id_info>
    <org_study_id>PER977-01-004</org_study_id>
    <nct_id>NCT02205905</nct_id>
  </id_info>
  <brief_title>An Open-label, Single-dose, Non-randomized Study of IV 14C-labeled PER977 in Healthy Male Subjects</brief_title>
  <official_title>An Open-label, Single-dose, Non-randomized Study of the Absorption, Metabolism, and Excretion of Intravenously Administered 14C-labeled PER977 in Healthy Male Subjects</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Perosphere Pharmaceuticals Inc, a wholly owned subsidiary of AMAG Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>World Wide Clinical Trials Early Phase Services, LLC</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>AMAG Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, single-dose, non-randomized study in healthy male subjects to&#xD;
      characterize the mass balance, metabolic disposition, and identification of the metabolites&#xD;
      and general metabolic pathways following administration of a single dose of IV solution&#xD;
      containing 200 mg of PER977 plus a tracer amount of 14C PER977 in health male subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mass balance of PER977 and metabolite</measure>
    <time_frame>3 weeks</time_frame>
    <description>To characterize the mass balance, metbaolic disposition, and identification of the metabolites and general metabolic pathways following administration of a single dose of IV solution containing 200 mg of PER977 plus a tracer amount of 14C PER977 to healthy male subjects</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with adverse events</measure>
    <time_frame>3 weeks</time_frame>
    <description>To assess the safety and tolerability of a single intravenous dose of 200 mg PER977</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>14C PER977</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open-label, single-dose, non-randomized study of 14C PER977 in six healthy male subjects</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>14C PER977</intervention_name>
    <description>Open-label, single dose</description>
    <arm_group_label>14C PER977</arm_group_label>
    <other_name>ciraprantag</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male&#xD;
&#xD;
          2. 18-55 years of age (inclusive)&#xD;
&#xD;
          3. Body mass index 18-32 kg/m2 (inclusive) and a minimum of 50 kg (110 lbs)&#xD;
&#xD;
          4. voluntarily consent to participate and provide written informed consent prior to start&#xD;
             of study specific procedures&#xD;
&#xD;
          5. Willing and able to remain in the study unit for the entire duration of the&#xD;
             confinement period&#xD;
&#xD;
          6. Willing to collect all urine and fecal samples for the duration of the study period as&#xD;
             required&#xD;
&#xD;
          7. Will to eat entire meals and snacks provided during confinement at the research&#xD;
             facility, and understand diet will include foods with high fiber content and possibly&#xD;
             prune juice&#xD;
&#xD;
          8. Willing to use a waterless commode located in a designated dry room for urine and&#xD;
             feces collection for the duration of the study period as required&#xD;
&#xD;
          9. Willing to abstain from showering for the first 72 hours following study drug&#xD;
             administration. After the restriction is lifted, willing to provide a urine sample&#xD;
             prior to showering for the remainder of the confinement period.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History or presence of clinically significant cardiovascular, pulmonary, hepatic,&#xD;
             renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic,&#xD;
             neurologic, oncologic, or psychiatric disease or any condition which, in the opinion&#xD;
             of the investigator, would jeopardize the safety of the subject or the validity of the&#xD;
             study results&#xD;
&#xD;
          2. Clinically significant abnormal finding on the physical exam, medical history,&#xD;
             electrocardiogram or clinical laboratory resutls at screening&#xD;
&#xD;
          3. History or presence of allergic or adverse response to anticoagulant reversal agents&#xD;
             or related drugs&#xD;
&#xD;
          4. Significantly abnormal diet within 4 weeks&#xD;
&#xD;
          5. Donated blood or plasma within 30 days&#xD;
&#xD;
          6. Participated in another clinical trial (randomized subjects only) within 30 days&#xD;
&#xD;
          7. Participated in a radiolabeled clinical trial within the last 12 months&#xD;
&#xD;
          8. Used any over-the-counter medication, including nutritional supplements, within 7 days&#xD;
&#xD;
          9. Used any prescription medication within 14 days prior&#xD;
&#xD;
         10. Treated with any known drugs that are moderate or strong inhibitors/inducers of CYP&#xD;
             enzymes such as barbiturates,phenothiazines, cimetidine, carbamazepine, etc. within 30&#xD;
             days&#xD;
&#xD;
         11. Smoked or used tobacco products within 60 days&#xD;
&#xD;
         12. History of substance abuse or treatment (including alcohol ) within the past 2 years&#xD;
&#xD;
         13. Positive urine screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines,&#xD;
             cocaine, cannabinoids, opiates) or cotinine at screening or check-in&#xD;
&#xD;
         14. Positive test for hepatitis B surface antigen, hepatitis C antibody or human&#xD;
             immunodeficiency virus at screening or has previously been treated for hepatitis B,&#xD;
             hepatitis C or HIV infection&#xD;
&#xD;
         15. Has irregular bowel habits&#xD;
&#xD;
         16. Has had significant radiation exposure within the prior 12 months&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cynthia A Zamora, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Worldwide Clinical Trials Early Phase Services</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Worldwide Clinical Trials Early Phase Services</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78217</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>May 19, 2020</last_update_submitted>
  <last_update_submitted_qc>May 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PER977</keyword>
  <keyword>metabolic disposition</keyword>
  <keyword>mass balance</keyword>
  <keyword>metabolites</keyword>
  <keyword>radiolabeled</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02205905
org study id: PER977-01-004
nct id: NCT02205905
lead sponsor: 
collaborator: 
has dmc: Yes
This is an open-label, single-dose, non-randomized study in healthy male subjects to
      characterize the mass balance, metabolic disposition, and identification of the metabolites
      and general metabolic pathways following administration of a single dose of IV solution
      containing 200 mg of PER977 plus a tracer amount of 14C PER977 in health male subjects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Mass balance of PER977 and metabolite
time frame: 3 weeks
description: To characterize the mass balance, metbaolic disposition, and identification of the metabolites and general metabolic pathways following administration of a single dose of IV solution containing 200 mg of PER977 plus a tracer amount of 14C PER977 to healthy male subjects
measure: Number of subjects with adverse events
time frame: 3 weeks
description: To assess the safety and tolerability of a single intravenous dose of 200 mg PER977
arm group label: 14C PER977
arm group type: Experimental
description: Open-label, single-dose, non-randomized study of 14C PER977 in six healthy male subjects
intervention type: Drug
intervention name: 14C PER977
description: Open-label, single dose
arm group label: 14C PER977
other name: ciraprantag
criteria: 
gender: Male
minimum age: 15 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Cynthia A Zamora, MD
role: Principal Investigator
affiliation: Worldwide Clinical Trials Early Phase Services
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No