Food Effect Study of CTP-543 in Healthy Volunteers

Concert Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: CTP-543

Study type

Interventional

Funder types

Industry

Identifiers

CP543.1003

Details and patient eligibility

About

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

Full 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.

Enrollment

14 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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