Multiple Ascending Dose Study of CTP-692 in Healthy Volunteers
- Registration Number
- NCT03880253
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description CTP-692 Low Dose or Matching Placebo CTP-692 Once daily dosing CTP-692 Mid Dose or Matching Placebo CTP-692 Once daily dosing CTP-692 High Dose or Matching Placebo CTP-692 Once daily dosing
- Primary Outcome Measures
Name Time Method Measurement of CTP-692 exposure in plasma Assessments done Day 1 - 9 Number of participants with adverse events as a measure of safety Assessments done Day 1 - 9
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Collaborative Neuroscience Network, LLC
🇺🇸Long Beach, California, United States