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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02680249

Enrollment

Registered

2016-02-11

Start date

2016-02-29

Completion date

2016-04-30

Last updated

2016-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Safety, Bioavailability and Pharmacokinetics

Brief 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.

Interventions

DRUGCTP-656

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026