NCT03778320

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1 healthy-volunteers

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

December 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2019

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

9 days

First QC Date

December 13, 2018

Last Update Submit

March 14, 2019

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • The number of AEs in participants as a measure of safety and tolerability.

    7 days

  • Measurement of CTP-692 exposure in plasma

    48 hours

Study Arms (2)

CTP-692

EXPERIMENTAL
Drug: CTP-692

D-Serine

ACTIVE COMPARATOR
Drug: D-Serine

Interventions

CTP-692DRUG

Single oral dose

CTP-692
D-SerineDRUG

Single oral dose

D-Serine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

Location

Study Officials

  • Emily McIntyre

    Concert Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2018

First Posted

December 19, 2018

Study Start

December 14, 2018

Primary Completion

December 23, 2018

Study Completion

January 31, 2019

Last Updated

March 15, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)