Food Effect Study of CTP-656 in Healthy Male Volunteers

Concert Pharmaceuticals15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

CTP-656DRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CMAX

Adelaide, South Australia, Australia

Outcomes

Primary Outcomes

Measurement of CTP-656 in plasma under fed and fasted conditions

Geometric mean ratio of moderate-fat versus low-fat or fasted

Time frame: 96 hours

Data from ClinicalTrials.gov

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