Food Effect Study of CTP-543 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CTP-543

• Registration Number: NCT03880136
• Lead Sponsor: Concert Pharmaceuticals

Brief Summary

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

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 Timeline

• Study First Submitted: 2019-03-15
• Study First Submitted QC: 2019-03-15
• Study First Posted: 2019-03-19
• Study Start: 2019-03-25
• Primary Completion: 2019-04-05
• Study Completion: 2019-04-05
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-12
• Last Update Posted: 2019-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Sequence 1	CTP-543	Period 1: CTP-543 with meal Period 2: CTP-543 without meal
Sequence 2	CTP-543	Period 1: CTP-543 without meal Period 2: CTP-543 with meal

Primary Outcome Measures

Name	Time	Method
Measurement of CTP-543 in plasma under fed and fasted conditions	48 hours

Trial Locations

Locations (1)

Celerion, Inc.; 🇺🇸 Tempe, Arizona, United States