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Multiple Ascending Dose Study of CTP-692 in Healthy Volunteers

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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

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.

Condition or disease Intervention/treatment Phase
Healthy Drug: CTP-692 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of CTP-692 in Healthy Volunteers
Actual Study Start Date : April 10, 2019
Actual Primary Completion Date : May 16, 2019
Actual Study Completion Date : May 16, 2019

Arm Intervention/treatment
Experimental: CTP-692 Low Dose or Matching Placebo
Once daily dosing
Drug: CTP-692
Placebo or CTP-692

Experimental: CTP-692 Mid Dose or Matching Placebo
Once daily dosing
Drug: CTP-692
Placebo or CTP-692

Experimental: CTP-692 High Dose or Matching Placebo
Once daily dosing
Drug: CTP-692
Placebo or CTP-692




Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety [ Time Frame: Assessments done Day 1 - 9 ]
  2. Measurement of CTP-692 exposure in plasma [ Time Frame: Assessments done Day 1 - 9 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03880253


Locations
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United States, California
Collaborative Neuroscience Network, LLC
Long Beach, California, United States, 90806
Sponsors and Collaborators
Concert Pharmaceuticals

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Responsible Party: Concert Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03880253     History of Changes
Other Study ID Numbers: CP692.1003
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: June 13, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No