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

NCT ID: NCT03778320

Last Updated: 2019-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-14

Study Completion Date

2019-01-31

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CTP-692

Group Type EXPERIMENTAL

CTP-692

Intervention Type DRUG

Single oral dose

D-Serine

Group Type ACTIVE_COMPARATOR

D-Serine

Intervention Type DRUG

Single oral dose

Interventions

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CTP-692

Single oral dose

Intervention Type DRUG

D-Serine

Single oral dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Concert Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emily McIntyre

Role: STUDY_DIRECTOR

Concert Pharmaceuticals, Inc.

Locations

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CMAX Clinical Research

Adelaide, South Australia, Australia

Site Status

Countries

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Australia

Other Identifiers

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CP692.1001

Identifier Type: -

Identifier Source: org_study_id

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