A Study to Compare the Safety, Tolerability, and Pharmacokinetics of CTP-692 Versus D-serine in Healthy Volunteers

Concert Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: CTP-692; Drug: D-Serine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03778320

CP692.1001

Details and patient eligibility

About

This study will assess the safety, tolerability and pharmacokinetic (PK) profile of CTP-692 vs D serine.

Enrollment: 13 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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13 participants in 2 patient groups

CTP-692

Experimental group

Treatment:

Drug: CTP-692

D-Serine

Active Comparator group

Treatment:

Drug: D-Serine