<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/NCT02190058</url>
  </required_header>
  <id_info>
    <org_study_id>DS1971-A-E102</org_study_id>
    <nct_id>NCT02190058</nct_id>
  </id_info>
  <brief_title>Multiple Dose Study of DS-1971a</brief_title>
  <official_title>A PHASE I, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED, MULTIPLE-DOSE STUDY TO ASSESS SAFETY, TOLERABILITY AND PHARMACOKINETICS OF DS-1971A IN HEALTHY MALE SUBJECTS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daiichi Sankyo, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daiichi Sankyo, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomised, double-blind, placebo-controlled multiple dose study designed to&#xD;
      explore the safety, tolerability and PK of DS-1971a following oral administration over 14&#xD;
      days to healthy male subjects.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>adverse events</measure>
    <time_frame>up to 2 months</time_frame>
    <description>To assess the safety and tolerability of repeated oral doses of DS-1971a in healthy male subjects the number, severity, and frequency of adverse events will be recorded from enrollment through discharge from study, up to 2 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>characterise the plasma pharmacokinetics AUC (area under curve)</measure>
    <time_frame>Day 1 through Day 17</time_frame>
    <description>To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.&#xD;
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F; Vss/F</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>characterise the plasma pharmacokinetics Cmax (maximum concentration)</measure>
    <time_frame>Day 1 through Day 17</time_frame>
    <description>To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.&#xD;
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F; Vss/F</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>characterise the plasma pharmacokinetics Tmax (time of maximum concentration)</measure>
    <time_frame>Day 1 through Day 17</time_frame>
    <description>To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.&#xD;
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F; Vss/F</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>characterise the plasma pharmacokinetics T½ (terminal half-life)</measure>
    <time_frame>Day 1 through Day 17</time_frame>
    <description>To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.&#xD;
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F; Vss/F</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>characterise the plasma pharmacokinetics CL/F (apparent oral clearance)</measure>
    <time_frame>Day 1 through Day 17</time_frame>
    <description>To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.&#xD;
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F (apparent oral clearance); Vss/F</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>characterise the plasma pharmacokinetics Vss/F (apparent volume of distribution)</measure>
    <time_frame>Day 1 through Day 17</time_frame>
    <description>To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.&#xD;
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F (apparent oral clearance); Vss/F (apparent volume of distribution).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>DS-1971a</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DS-1971a suspension, up to 4650mg/day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>matching DS-1971a suspension</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DS-1971a</intervention_name>
    <description>suspension</description>
    <arm_group_label>DS-1971a</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>placebo matching DS-1971a</description>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male subjects aged 18-55 years.&#xD;
&#xD;
          -  A body mass index (BMI) in the range 18-30 kg/m2, inclusive, and weighing between 50&#xD;
             and 100 kg at screening.&#xD;
&#xD;
          -  Willing to comply with all study restrictions, including the use of contraception,&#xD;
             concomitant medication, and dietary and lifestyle restrictions.&#xD;
&#xD;
          -  Sufficient intelligence to understand the nature of the study and any hazards of&#xD;
             participating in it. Ability to communicate satisfactorily with the Investigator and&#xD;
             to participate in, and comply with requirements of, the entire study.&#xD;
&#xD;
          -  Have given written consent to participate in the study after reading the ICF, and&#xD;
             after having the opportunity to discuss the study with the Investigator or his&#xD;
             delegate.&#xD;
&#xD;
          -  Have given written consent to have his data entered into The Over-volunteering&#xD;
             Prevention System.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically relevant abnormal history, physical findings, ECG findings, or laboratory&#xD;
             values that could interfere with the objectives of the study or compromise the safety&#xD;
             of the subject.&#xD;
&#xD;
          -  Presence or history of acute or chronic illness, including (but not limited to) liver&#xD;
             or kidney disease, hypertension, seizures, or any known impairment of endocrine, or&#xD;
             other specific body-organ dysfunction.&#xD;
&#xD;
          -  History of serious reaction to any medicine.&#xD;
&#xD;
          -  Presence or history of malignant disease.&#xD;
&#xD;
          -  Acute or chronic infectious disease, including human immunodeficiency virus (HIV),&#xD;
             hepatitis B virus (HBV) or C virus (HCV) infection.&#xD;
&#xD;
          -  Surgery (eg stomach bypass) or medical condition that might affect how the body&#xD;
             handles or absorbs medicines.&#xD;
&#xD;
          -  Significant illness within 4 weeks before the first dose of study medication.&#xD;
&#xD;
          -  Participation in another clinical study of a new chemical entity or a prescription&#xD;
             medicine within the previous 3 months, or unwilling to abstain from participating in&#xD;
             other clinical trials during the study and for 3 months after receipt of study&#xD;
             medication.&#xD;
&#xD;
          -  Participation in another clinical study with DS 1971a.&#xD;
&#xD;
          -  Abnormal ECG waveform morphology at screening that would preclude accurate measurement&#xD;
             of the QT interval duration.&#xD;
&#xD;
          -  Corrected QT interval (Fridericia's formula) (QTcF) interval duration &gt; 430 msec,&#xD;
             obtained as an average from the measurements on duplicate screening ECGs.&#xD;
&#xD;
          -  Estimated glomerular filtration rate (eGFR) &lt; 80 mL/min/1.73m2 (based on Modification&#xD;
             of Diet in Renal Disease [MDRD] equation) or an absolute creatinine value outside the&#xD;
             normal range.&#xD;
&#xD;
          -  Use of any prescription or over the counter (OTC) medications, or herbal remedies&#xD;
             (such as St John's wort), known to be strong inhibitors or strong inducers of&#xD;
             cytochrome (CYP) enzymes (also known as CYP P450 enzymes) during the 30 days before&#xD;
             the first dose of study medication; use of any other prescription or OTC medicine&#xD;
             (with the exception of acetaminophen (paracetamol)), including dietary supplements or&#xD;
             herbal remedies, during the 7 days before the dose of study medication.&#xD;
&#xD;
          -  Consumption of certain foods or beverages before the first dose and throughout the&#xD;
             study period.&#xD;
&#xD;
          -  Loss of more than 400 mL blood or donation of blood, plasma, platelets, or any other&#xD;
             blood components during the 3 months before the first dose of study medication, or&#xD;
             unwilling to abstain from doing so during the study and for 3 months after receipt of&#xD;
             study medication.&#xD;
&#xD;
          -  Abuse of drugs or alcohol during the 2 years before the first dose of study&#xD;
             medication, or intake of more than 21 units of alcohol weekly.&#xD;
&#xD;
          -  Use of tobacco products or nicotine-containing products during the 3 months before the&#xD;
             first dose of study medication and during the study.&#xD;
&#xD;
          -  Evidence of drug or alcohol abuse at screening or admission.&#xD;
&#xD;
          -  Likely possibility that the volunteer will not cooperate with the requirements of the&#xD;
             protocol.&#xD;
&#xD;
          -  Objection by GP to the volunteer entering the study.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hammersmith Medicines Research Ltd.</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>safety</keyword>
  <keyword>pharmacokinetics</keyword>
  <keyword>DS-1971a</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>DS-1971a</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.</ipd_time_frame>
    <ipd_access_criteria>Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/daiichi-sankyo/</ipd_url>
  </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/NCT02190058
org study id: DS1971-A-E102
nct id: NCT02190058
lead sponsor: 
has dmc: No
This is a randomised, double-blind, placebo-controlled multiple dose study designed to
      explore the safety, tolerability and PK of DS-1971a following oral administration over 14
      days to healthy male subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: adverse events
time frame: up to 2 months
description: To assess the safety and tolerability of repeated oral doses of DS-1971a in healthy male subjects the number, severity, and frequency of adverse events will be recorded from enrollment through discharge from study, up to 2 months.
measure: characterise the plasma pharmacokinetics AUC (area under curve)
time frame: Day 1 through Day 17
description: To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F; Vss/F
measure: characterise the plasma pharmacokinetics Cmax (maximum concentration)
time frame: Day 1 through Day 17
description: To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F; Vss/F
measure: characterise the plasma pharmacokinetics Tmax (time of maximum concentration)
time frame: Day 1 through Day 17
description: To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F; Vss/F
measure: characterise the plasma pharmacokinetics T½ (terminal half-life)
time frame: Day 1 through Day 17
description: To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F; Vss/F
measure: characterise the plasma pharmacokinetics CL/F (apparent oral clearance)
time frame: Day 1 through Day 17
description: To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F (apparent oral clearance); Vss/F
measure: characterise the plasma pharmacokinetics Vss/F (apparent volume of distribution)
time frame: Day 1 through Day 17
description: To characterise the plasma pharmacokinetics (PK) of DS-1971a in healthy male subjects receiving repeated oral doses.
plasma concentrations of DS 1971a, and derived PK parameters: AUC (area under curve); Cmax (maximum concentration); Tmax (time of maximum concentration), T½ (terminal half-life), CL/F (apparent oral clearance); Vss/F (apparent volume of distribution).
arm group label: DS-1971a
arm group type: Experimental
description: DS-1971a suspension, up to 4650mg/day
arm group label: placebo
arm group type: Placebo Comparator
description: matching DS-1971a suspension
intervention type: Drug
intervention name: DS-1971a
description: suspension
arm group label: DS-1971a
intervention type: Drug
intervention name: placebo
description: placebo matching DS-1971a
arm group label: placebo
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: DS-1971a
sharing ipd: Yes
ipd description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
ipd access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
ipd url: https://vivli.org/ourmember/daiichi-sankyo/