Food Effect Study of CTP-543 in Healthy Volunteers

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measurement of CTP-543 in plasma under fed and fasted conditions	48 hours

Collaborators and Investigators

• Sponsor: Concert Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2019
• Primary Completion (Actual): April 5, 2019
• Study Completion (Actual): April 5, 2019

Study Registration Dates

• First Submitted: March 15, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): June 13, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Keywords: Safety; Pharmacokinetics; Bioavailability
• Other Study ID Numbers: CP543.1003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No