Study to Evaluate Safety, Tolerability, Pharmacokinetics... | NCT02777008

Studies
Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CTP-543 in Healthy Subjects

NCT02777008

Sponsor

Concert Pharmaceuticals

Status

Completed

Last Update Posted

Mar 13, 2017Actual

Enrollment

77Actual

Phase

Phase 1

Conditions

Healthy

Interventions

CTP-543
Placebo for CTP-543

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 2017

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

May 2016

Primary Completion Date

Dec 2016Actual

Completion Date

Mar 2017Actual

First Submitted Date

May 16, 2016

First Submission Date that Met QC Criteria

May 17, 2016

First Posted Date

May 19, 2016Estimated

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 10, 2017

Last Update Posted Date

Mar 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

Single- and multiple-ascending dose study of CTP-543 in healthy volunteers.

Detailed Description

This two-part study will assess, in healthy volunteers, under fasted conditions, and in a sequential manner, the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple-ascending doses of CTP-543.

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

77Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CTP-543 Single Dose	Experimental	Single oral dose	Drug: CTP-543 Drug: Placebo for CTP-543
CTP-543 Multiple Dose	Experimental	Multiple oral dose for 7 consecutive days	Drug: CTP-543 Drug: Placebo for CTP-543

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CTP-543	Drug		CTP-543 Multiple Dose CTP-543 Single Dose
Placebo for CTP-543

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability		24 hours
Measurement of CTP-543 exposure in plasma under fasted conditions		24 hours

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
The relationship between CTP-543 drug concentration and effect		7 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adult males and females between 18 and 50 years of age, inclusive
Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive

Exclusion Criteria:

History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal, hepatic, or gastrointestinal (GI) 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
History of herpes zoster
Hemoglobin, white blood cell, or platelet levels below the lower reference limit at screening or prior to the first dose of study drug
Liver function tests greater than the upper limit of normal
Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B virus surface antigen, or hepatitis C virus antibody
Urinalysis positive for protein or glucose
A positive screen for alcohol, drugs of abuse, or tobacco use
Donation of blood, plasma or other blood products prior to screening
A positive tuberculosis test

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Colleen Hamilton	Concert Pharmaceuticals, Inc.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
		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