Study to Assess the Safety and Pharmacokinetic (PK) of CTP-692 in Healthy Volunteers
- Registration Number
- NCT03830463
- Lead Sponsor
- Concert Pharmaceuticals
- Brief Summary
This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses of CTP-692 in healthy volunteers.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- Healthy adult males and females between 18 and 55 years of age, inclusive
- Body weight ≥ 55 kg and BMI 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 CTP-692 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Number of Participants with Adverse Events as a Measure of Safety 48 hours Measurement of CTP-692 exposure in plasma under fasted conditions 48 hours Measurement of CTP-692 exposure in plasma under fed conditions 48 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Collaborative Neuroscience Network, LLC
🇺🇸Long Beach, California, United States