Food Effect Study of CTP-656 in Healthy Male Volunteers

NCT ID: NCT02680249

Last Updated: 2016-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2016-04-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

CTP-656 Fed, low fat

Single dose of CTP-656 150 mg administered after a low-fat breakfast

Group Type: EXPERIMENTAL

CTP-656

Intervention Type: DRUG

CTP-656 Fasted

Single dose of CTP-656 150 mg administered fasted

Group Type: EXPERIMENTAL

CTP-656

Intervention Type: DRUG

CTP-656 Fed, high fat

Single dose of CTP-656 150 mg administered after a moderate-fat breakfast

Group Type: EXPERIMENTAL

CTP-656

Intervention Type: DRUG

Interventions

CTP-656

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Concert Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lana Pilja

Role: STUDY_DIRECTOR

Concert Pharmaceuticals, Inc.

Locations

CMAX

Adelaide, South Australia, Australia

Countries

Australia

Other Identifiers

CP656.1003

Identifier Type: -

Identifier Source: org_study_id