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Multiple Ascending Dose Study of CTP-692 in Healthy Volunteers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03880253
Recruitment Status : Completed
First Posted : March 19, 2019
Last Update Posted : June 13, 2019
Sponsor:
Information provided by (Responsible Party):
Concert Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE March 15, 2019
First Posted Date  ICMJE March 19, 2019
Last Update Posted Date June 13, 2019
Actual Study Start Date  ICMJE April 10, 2019
Actual Primary Completion Date May 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 15, 2019)
  • Number of participants with adverse events as a measure of safety [ Time Frame: Assessments done Day 1 - 9 ]
  • Measurement of CTP-692 exposure in plasma [ Time Frame: Assessments done Day 1 - 9 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03880253 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multiple Ascending Dose Study of CTP-692 in Healthy Volunteers
Official Title  ICMJE A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of CTP-692 in Healthy Volunteers
Brief Summary This study will assess in healthy male and female subjects the safety and pharmacokinetic (PK) profiles of 3 dose levels of CTP-692 following 7 days of dosing.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE Drug: CTP-692
Placebo or CTP-692
Study Arms  ICMJE
  • Experimental: CTP-692 Low Dose or Matching Placebo
    Once daily dosing
    Intervention: Drug: CTP-692
  • Experimental: CTP-692 Mid Dose or Matching Placebo
    Once daily dosing
    Intervention: Drug: CTP-692
  • Experimental: CTP-692 High Dose or Matching Placebo
    Once daily dosing
    Intervention: Drug: CTP-692
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 16, 2019
Actual Primary Completion Date May 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy adult males and females between 18 and 55 years of age, inclusive
  • Body weight ≥ 55 kg and body mass index within the range of 18 to 32 kg/m2, inclusive

Exclusion Criteria:

  • Screening laboratory measurements outside the normal range associated with potential risk for the treatment under investigation at screening and/or prior to the first dose of study drug
  • Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen or hepatitis C virus antibody
  • History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal (GI) conditions
  • Positive drug or alcohol test at screening or prior to the first dose of study drug
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03880253
Other Study ID Numbers  ICMJE CP692.1003
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Concert Pharmaceuticals
Study Sponsor  ICMJE Concert Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Concert Pharmaceuticals
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP