Food Effect Study of CTP-656 in Healthy Male Volunteers

A Phase 1 Single Center, Open-Label, Randomized, Three-Way Crossover Study of the Relative Bioavailability of a Single Dose of CTP-656 in a Fasted, Fed Low-Fat and Fed Moderate-Fat Condition in Healthy Male Subjects

Three way crossover study to assess the bioavailability of 656 under fed and fasted conditions.

This study will assess in healthy male subjects a solid oral dose formulation of CTP-656 under fasted and fed conditions.

Primary:

• To characterize the relative bioavailability and pharmacokinetic profile of a single 150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat conditions.

Secondary:

• To characterize the pharmacokinetic profile of metabolites of CTP-656 following a single 150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat conditions.
• To assess the safety and tolerability following a single 150 mg solid oral dose of CTP-656 in healthy volunteers under fasted, fed low-fat and fed moderate-fat conditions.

Inclusion Criteria:

• Healthy adults between 18 and 50 years of age, inclusive
• Body weight ≥ 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive, at screening

Exclusion Criteria:

• History of clinically significant central nervous system (eg, seizures), cardiac, pulmonary, metabolic, renal (including nephrolithiasis), hepatic, including history of Gilbert's syndrome or gastrointestinal (GI) 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
• Liver function tests greater than the upper limit of normal.
• 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
• A positive screen for alcohol, drugs of abuse, or tobacco use.
• Inability to comply with dietary restrictions during study participation.
• Donation or blood collection or acute loss of blood prior to screening.