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

Sponsor

Concert Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT03778320

Collaborator

(none)

Enrollment

Location

Arms

1.6

Actual Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: CTP-692 Drug: D-Serine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

13 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 14, 2018

Actual Primary Completion Date :

Dec 23, 2018

Actual Study Completion Date :

Jan 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CTP-692	Drug: CTP-692 Single oral dose
Active Comparator: D-Serine	Drug: D-Serine Single oral dose

Arm

Intervention/Treatment

Experimental: CTP-692

Drug: CTP-692

Single oral dose

Active Comparator: D-Serine

Drug: D-Serine

Single oral dose

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CMAX Clinical Research	Adelaide	South Australia	Australia	5000

Sponsors and Collaborators

Concert Pharmaceuticals

Investigators

Study Director: Emily McIntyre, Concert Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Concert Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT03778320

Other Study ID Numbers:

CP692.1001

First Posted:

Dec 19, 2018

Last Update Posted:

Mar 15, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Mar 15, 2019