A Study to Compare the Safety, Tolerability, and Pharmaco... | NCT03778320

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

NCT03778320

Sponsor

Concert Pharmaceuticals

Status

Completed

Last Update Posted

Mar 15, 2019Actual

Enrollment

13Actual

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

CTP-692
D-Serine

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 14, 2018Actual

Primary Completion Date

Dec 23, 2018Actual

Completion Date

Jan 31, 2019Actual

First Submitted Date

Dec 13, 2018

First Submission Date that Met QC Criteria

Dec 17, 2018

First Posted Date

Dec 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2019

Last Update Posted Date

Mar 15, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

13Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CTP-692	Experimental		Drug: CTP-692
D-Serine	Active Comparator		Drug: D-Serine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CTP-692	Drug	Single oral dose	CTP-692
D-Serine

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Emily McIntyre	Concert Pharmaceuticals, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CMAX Clinical Research		Adelaide	South Australia	5000	Australia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided