NCT02680249

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Concert Pharmaceuticals · Industry
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	CTP-656

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-04-01
• Completion: 2016-04-01
• First posted: 2016-02-11
• Last updated: 2016-05-02

Locations

1 site across 1 country: Australia