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

• Sponsor: Concert Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02777008
• Collaborator: (none)
• Enrollment: 77
• Location: 1
• Arms: 2
• Duration (Months): 10
• Patients Per Site Per Month: 7.7

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: CTP-543; Drug: Placebo for CTP-543	Phase 1

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 Design

• Study Type: Interventional
• Actual Enrollment: 77 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Basic Science
• Official Title: 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
• Study Start Date: May 1, 2016
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Mar 1, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [24 hours]

2. Measurement of CTP-543 exposure in plasma under fasted conditions [24 hours]

Other Outcome Measures

1. The relationship between CTP-543 drug concentration and effect [7 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Adelaide	South Australia	Australia	5000

Sponsors and Collaborators

• Concert Pharmaceuticals

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Concert Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02777008
• Other Study ID Numbers: CP543.1001
• First Posted: May 19, 2016
• Last Update Posted: Mar 13, 2017
• Last Verified: Mar 1, 2017

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

Study Results

No Results Posted as of Mar 13, 2017