Status:
COMPLETED
A Study to Compare the Safety, Tolerability, and Pharmacokinetics of CTP-692 Versus D-serine in Healthy Volunteers
Lead Sponsor:
Concert Pharmaceuticals
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will assess the safety, tolerability and pharmacokinetic (PK) profile of CTP-692 vs D serine.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2019
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03778320
Start Date
December 14 2018
End Date
January 31 2019
Last Update
March 15 2019
Active Locations (1)
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1
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000