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.

This open-label, single-dose study will assess in healthy subjects a solid oral dose formulation of CTP-543 under fasted and fed conditions.

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