NCT03880253CompletedPhase 1
A Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetic Profile of CTP-692 in Healthy Volunteers
Concert Pharmaceuticals1 site in 1 country30 target enrollmentStarted: April 10, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Measurement of CTP-692 exposure in plasma
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
CTP-692 Low Dose or Matching Placebo
Experimental
Once daily dosing
Intervention: CTP-692 (Drug)
CTP-692 Mid Dose or Matching Placebo
Experimental
Once daily dosing
Intervention: CTP-692 (Drug)
CTP-692 High Dose or Matching Placebo
Experimental
Once daily dosing
Intervention: CTP-692 (Drug)
Outcomes
Primary Outcomes
Measurement of CTP-692 exposure in plasma
Time Frame: Assessments done Day 1 - 9
Number of participants with adverse events as a measure of safety
Time Frame: Assessments done Day 1 - 9
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
Loading locations...
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