Study to Assess the Safety and Pharmacokinetic (PK) of CT... | NCT03830463

Studies
Study to Assess the Safety and Pharmacokinetic (PK) of CTP-692 in Healthy Volunteers

NCT03830463

Sponsor

Concert Pharmaceuticals

Status

Completed

Last Update Posted

Jun 13, 2019Actual

Enrollment

42Actual

Phase

Phase 1

Conditions

Healthy

Interventions

CTP-692
Placebo

Countries

United States

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

Jun 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

Jan 24, 2019Actual

Primary Completion Date

Mar 28, 2019Actual

Completion Date

Mar 28, 2019Actual

First Submitted Date

Feb 2, 2019

First Submission Date that Met QC Criteria

Feb 2, 2019

First Posted Date

Feb 5, 2019Actual

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

Jun 12, 2019

Last Update Posted Date

Jun 13, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Yes

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

Description Module

Brief Summary

This study will assess the safety and pharmacokinetic (PK) profile of single ascending doses of CTP-692 in healthy volunteers.

Detailed Description

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

42Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CTP-692	Experimental		Drug: CTP-692
Placebo	Placebo Comparator		Drug: Placebo

Interventions

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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety		48 hours
Measurement of CTP-692 exposure in plasma under fasted conditions		48 hours
Measurement of CTP-692 exposure in plasma under fed conditions		48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult males and females between 18 and 55 years of age, inclusive
Body weight ≥ 55 kg and BMI within the range of 18 to 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
Collaborative Neuroscience Network, LLC		Long Beach	California	90806	United States

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