A Study to Compare the Safety, Tolerability, and Pharmacokinetics of CTP-692 Versus D-serine in Healthy Volunteers
- Registration Number
- NCT03778320
- Lead Sponsor
- Concert Pharmaceuticals
- Brief Summary
This study will assess the safety, tolerability and pharmacokinetic (PK) profile of CTP-692 vs D serine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Inclusion Criteria
- Must give written and informed consent and any authorizations required by local law.
- Must have a body mass index (BMI) between 18 kg/m2 and 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
- CROSSOVER
- Arm && Interventions
Group Intervention Description CTP-692 CTP-692 - D-Serine D-Serine -
- Primary Outcome Measures
Name Time Method The number of AEs in participants as a measure of safety and tolerability. 7 days Measurement of CTP-692 exposure in plasma 48 hours
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
CMAX Clinical Research
🇦🇺Adelaide, South Australia, Australia