Food Effect Study of CTP-543 in Healthy Volunteers

• Sponsor: Concert Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03880136
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 2
• Actual Duration (Days): 11
• Patients Per Site Per Month: 38.7

Study Details

Study Description

Brief Summary

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

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

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: A Phase 1 Single Center, Open-Label, Randomized Two-Period, Two-Arm Crossover Study of the Relative Bioavailability of a Single Dose of CTP-543 in Fasted and Fed Conditions in Healthy Volunteers
• Actual Study Start Date: Mar 25, 2019
• Actual Primary Completion Date: Apr 5, 2019
• Actual Study Completion Date: Apr 5, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence 1 Period 1: CTP-543 with meal Period 2: CTP-543 without meal	Drug: CTP-543; Once daily dosing
Experimental: Sequence 2 Period 1: CTP-543 without meal Period 2: CTP-543 with meal	Drug: CTP-543; Once daily dosing

Outcome Measures

Primary Outcome Measures

1. Measurement of CTP-543 in plasma under fed and fasted conditions [48 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Celerion, Inc.	Tempe	Arizona	United States	85283

Sponsors and Collaborators

• Concert Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Concert Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03880136
• Other Study ID Numbers: CP543.1003
• First Posted: Mar 19, 2019
• Last Update Posted: Jun 13, 2019
• Last Verified: Jun 1, 2019

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Concert Pharmaceuticals: Safety; Bioavailability; Pharmacokinetics

Study Results

No Results Posted as of Jun 13, 2019