Food Effect Study of CTP-543 in Healthy Volunteers | NCT03880136

Studies
Food Effect Study of CTP-543 in Healthy Volunteers

NCT03880136

Sponsor

Concert Pharmaceuticals

Status

Completed

Last Update Posted

Jun 13, 2019Actual

Enrollment

14Actual

Phase

Phase 1

Conditions

Healthy

Interventions

CTP-543

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

Mar 25, 2019Actual

Primary Completion Date

Apr 5, 2019Actual

Completion Date

Apr 5, 2019Actual

First Submitted Date

Mar 15, 2019

First Submission Date that Met QC Criteria

Mar 15, 2019

First Posted Date

Mar 19, 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

Two period crossover study to assess the bioavailability of CTP-543 under fed and fasted conditions.

Detailed Description

This open-label, single-dose study will assess in healthy subjects a solid oral dose formulation of CTP-543 under fasted and fed conditions.

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

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sequence 1	Experimental	Period 1: CTP-543 with meal Period 2: CTP-543 without meal	Drug: CTP-543
Sequence 2	Experimental	Period 1: CTP-543 without meal Period 2: CTP-543 with meal	Drug: CTP-543

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CTP-543	Drug	Once daily dosing	Sequence 1 Sequence 2

Measure	Description	Time Frame
Measurement of CTP-543 in plasma under fed and fasted conditions		48 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adults between 18 and 55 years of age, inclusive
Body weight not less than 100 lbs and body mass index within the range of 18 to 32 kg/m2, inclusive, at screening

Exclusion Criteria:

History of clinically significant central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal conditions
PR interval > 220 msec or QRS duration > 120 msec or QTcF interval > 450 msec obtained at screening visit 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 at screening
Urinalysis positive for greater than trace blood, protein or glucose
History of drug or alcohol abuse within 6 months of screening
History of tobacco product use within 3 months prior to the study
Inability to comply with dietary restrictions during study participation
Blood donation or collection within 8 week prior to dosing
Positive pregnancy test

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