Food Effect Study of CTP-656 in Healthy Male Volunteers

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

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: CTP-656


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTP-656 Fed, low fat<br>Single dose of CTP-656 150 mg administered after a low-fat breakfast | Drug: CTP-656<br> <br> |
| Experimental: CTP-656 Fasted<br>Single dose of CTP-656 150 mg administered fasted | Drug: CTP-656<br> <br> |
| Experimental: CTP-656 Fed, high fat<br>Single dose of CTP-656 150 mg administered after a moderate-fat breakfast | Drug: CTP-656<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of CTP-656 in plasma under fed and fasted conditions | Geometric mean ratio of moderate-fat versus low-fat or fasted | 96 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Safety, Bioavailability and Pharmacokinetics