Food Effect Study of CTP-656 in Healthy Male Volunteers
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|ClinicalTrials.gov Identifier: NCT02680249|
Recruitment Status : Completed
First Posted : February 11, 2016
Last Update Posted : May 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: CTP-656||Phase 1|
This study will assess in healthy male subjects a solid oral dose formulation of CTP-656 under fasted and fed conditions.
• 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.
- 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 (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||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|
|Study Start Date :||February 2016|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
Experimental: CTP-656 Fed, low fat
Single dose of CTP-656 150 mg administered after a low-fat breakfast
Experimental: CTP-656 Fasted
Single dose of CTP-656 150 mg administered fasted
Experimental: CTP-656 Fed, high fat
Single dose of CTP-656 150 mg administered after a moderate-fat breakfast
- Measurement of CTP-656 in plasma under fed and fasted conditions [ Time Frame: 96 hours ]Geometric mean ratio of moderate-fat versus low-fat or fasted
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02680249
|Australia, South Australia|
|Adelaide, South Australia, Australia, 5000|
|Study Director:||Lana Pilja||Concert Pharmaceuticals, Inc.|