<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/NCT02239081</url>
  </required_header>
  <id_info>
    <org_study_id>CP730.1001</org_study_id>
    <nct_id>NCT02239081</nct_id>
  </id_info>
  <brief_title>A Safety and Tolerability Study of CTP-730 in Healthy Volunteers</brief_title>
  <official_title>A Randomized, Double-blind, Single Ascending Dose, Safety, Tolerability, Pharmacokinetics Study of CTP-730 in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Concert Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Concert Pharmaceuticals</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase 1, single center, single-ascending dose, randomized study&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following a Screening period of up to 21 days, eight (8) subjects in each cohort, 6 subjects&#xD;
      randomized to CTP-730 and 2 subjects randomized to placebo, will be admitted to the clinical&#xD;
      research unit (CRU) on the evening before dosing and remain sequestered at the study site&#xD;
      until after the last inpatient blood sample is collected at 48 hours.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</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>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number and severity of adverse events</measure>
    <time_frame>3 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Pharmacokinetics parameters</measure>
    <time_frame>96 hours</time_frame>
    <description>Peak plasma concentration - Cmax by dose Area under the plasma concentration by time - AUC by dose</description>
  </primary_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>CTP-730, 5 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>oral suspension, once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTP-730, 10 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral Suspension, once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTP-730, 20 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral Suspension, once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTP-730, 30 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral Suspension, once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTP-730, 40 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral Suspension, once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTP-730, 50 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral Suspension, once daily.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTP-730, 60 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral Suspension, once daily.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CTP-730</intervention_name>
    <arm_group_label>CTP-730, 10 mg</arm_group_label>
    <arm_group_label>CTP-730, 20 mg</arm_group_label>
    <arm_group_label>CTP-730, 30 mg</arm_group_label>
    <arm_group_label>CTP-730, 40 mg</arm_group_label>
    <arm_group_label>CTP-730, 5 mg</arm_group_label>
    <arm_group_label>CTP-730, 50 mg</arm_group_label>
    <arm_group_label>CTP-730, 60 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo for CTP-730</intervention_name>
    <arm_group_label>CTP-730, 10 mg</arm_group_label>
    <arm_group_label>CTP-730, 20 mg</arm_group_label>
    <arm_group_label>CTP-730, 30 mg</arm_group_label>
    <arm_group_label>CTP-730, 40 mg</arm_group_label>
    <arm_group_label>CTP-730, 5 mg</arm_group_label>
    <arm_group_label>CTP-730, 50 mg</arm_group_label>
    <arm_group_label>CTP-730, 60 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy male and female volunteer subjects, 18 to 50 years of age, inclusive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current significant medical condition, laboratory abnormality, or psychiatric illness&#xD;
&#xD;
          -  History of clinically significant central nervous system (eg, seizures), cardiac,&#xD;
             pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) conditions&#xD;
&#xD;
          -  PR interval ≥ 220 msec or QRS duration ≥ 120 msec or QTcB / QTcF interval &gt; 450 msec&#xD;
&#xD;
          -  Elevated liver function tests greater than twice the upper limit of normal&#xD;
&#xD;
          -  Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B&#xD;
             virus surface antigen, or hepatitis C virus antibody&#xD;
&#xD;
          -  Urinalysis positive for protein or glucose&#xD;
&#xD;
          -  A positive screen for alcohol, drugs of abuse, or tobacco use.&#xD;
&#xD;
          -  Inability to comply with food and beverage restrictions during study participation&#xD;
&#xD;
          -  Donation or blood collection or acute loss of blood prior to screening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ginny Braman</last_name>
    <role>Study Director</role>
    <affiliation>Concert Pharmaceuticals, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CMAX</name>
      <address>
        <city>Adelaide</city>
        <state>South Australia</state>
        <zip>5000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>May 28, 2015</last_update_submitted>
  <last_update_submitted_qc>May 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 29, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pharmacokinetics</keyword>
  <keyword>Safety</keyword>
  <!-- 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/NCT02239081
org study id: CP730.1001
nct id: NCT02239081
lead sponsor: 
has dmc: Yes
This is a Phase 1, single center, single-ascending dose, randomized study
Following a Screening period of up to 21 days, eight (8) subjects in each cohort, 6 subjects
      randomized to CTP-730 and 2 subjects randomized to placebo, will be admitted to the clinical
      research unit (CRU) on the evening before dosing and remain sequestered at the study site
      until after the last inpatient blood sample is collected at 48 hours.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number and severity of adverse events
time frame: 3 days
measure: Pharmacokinetics parameters
time frame: 96 hours
description: Peak plasma concentration - Cmax by dose Area under the plasma concentration by time - AUC by dose
arm group label: CTP-730, 5 mg
arm group type: Experimental
description: oral suspension, once daily.
arm group label: CTP-730, 10 mg
arm group type: Experimental
description: Oral Suspension, once daily.
arm group label: CTP-730, 20 mg
arm group type: Experimental
description: Oral Suspension, once daily.
arm group label: CTP-730, 30 mg
arm group type: Experimental
description: Oral Suspension, once daily.
arm group label: CTP-730, 40 mg
arm group type: Experimental
description: Oral Suspension, once daily.
arm group label: CTP-730, 50 mg
arm group type: Experimental
description: Oral Suspension, once daily.
arm group label: CTP-730, 60 mg
arm group type: Experimental
description: Oral Suspension, once daily.
intervention type: Drug
intervention name: CTP-730
arm group label: CTP-730, 10 mg
arm group label: CTP-730, 20 mg
arm group label: CTP-730, 30 mg
arm group label: CTP-730, 40 mg
arm group label: CTP-730, 5 mg
arm group label: CTP-730, 50 mg
arm group label: CTP-730, 60 mg
intervention type: Drug
intervention name: Placebo for CTP-730
arm group label: CTP-730, 10 mg
arm group label: CTP-730, 20 mg
arm group label: CTP-730, 30 mg
arm group label: CTP-730, 40 mg
arm group label: CTP-730, 5 mg
arm group label: CTP-730, 50 mg
arm group label: CTP-730, 60 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ginny Braman
role: Study Director
affiliation: Concert Pharmaceuticals, Inc.
facility: 
country: Australia
responsible party type: Sponsor