NCT02777008

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started May 2016

Longer than P75 for phase_1 healthy

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

Study Start

First participant enrolled

May 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

March 13, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

May 16, 2016

Last Update Submit

March 10, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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

Other Outcomes (1)

  • The relationship between CTP-543 drug concentration and effect

    7 days

Study Arms (2)

CTP-543 Single Dose

EXPERIMENTAL

Single oral dose

Drug: CTP-543Drug: Placebo for CTP-543

CTP-543 Multiple Dose

EXPERIMENTAL

Multiple oral dose for 7 consecutive days

Drug: CTP-543Drug: Placebo for CTP-543

Interventions

CTP-543DRUG
CTP-543 Multiple DoseCTP-543 Single Dose
Placebo for CTP-543DRUG
CTP-543 Multiple DoseCTP-543 Single Dose

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Adelaide, South Australia, 5000, Australia

Location

Study Officials

  • Colleen Hamilton

    Concert Pharmaceuticals, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2016

First Posted

May 19, 2016

Study Start

May 1, 2016

Primary Completion

December 1, 2016

Study Completion

March 1, 2017

Last Updated

March 13, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)