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

A Two-Part Single Center, Randomized, Sequential, Single and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTP-543 in Healthy Volunteers

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: CTP-543; Drug: Placebo for CTP-543

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • South Australia
    • Adelaide, South Australia, Australia, 5000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CTP-543 Single Dose; Single oral dose	Drug: CTP-543; Drug: Placebo for CTP-543
Experimental: CTP-543 Multiple Dose; Multiple oral dose for 7 consecutive days	Drug: CTP-543; Drug: Placebo for CTP-543

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Concert Pharmaceuticals
• Investigators: Study Director: Colleen Hamilton, Concert Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: May 16, 2016
• First Submitted That Met QC Criteria: May 17, 2016
• First Posted (Estimate): May 19, 2016

Study Record Updates

• Last Update Posted (Actual): March 13, 2017
• Last Update Submitted That Met QC Criteria: March 10, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CP543.1001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No