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

A Randomized Single Dose Crossover Comparison of the Safety, Tolerability, and Pharmacokinetic Profile of CTP-692 Versus D-Serine

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03778320

Enrollment

Registered

2018-12-19

Start date

2018-12-14

Completion date

2019-01-31

Last updated

2019-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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

Interventions

DRUGCTP-692

Single oral dose

DRUGD-Serine

Single oral dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
The number of AEs in participants as a measure of safety and tolerability.	7 days
Measurement of CTP-692 exposure in plasma	48 hours

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026