Food Effect Study of CTP-656 in Healthy Male Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: CTP-656

• Registration Number: NCT02680249
• Lead Sponsor: Concert Pharmaceuticals

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.

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-02-03
• Study First Submitted QC: 2016-02-08
• Study First Posted: 2016-02-11
• Status Verified: 2016-04
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-29
• Last Update Posted: 2016-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
CTP-656 Fed, low fat	CTP-656	Single dose of CTP-656 150 mg administered after a low-fat breakfast
CTP-656 Fasted	CTP-656	Single dose of CTP-656 150 mg administered fasted
CTP-656 Fed, high fat	CTP-656	Single dose of CTP-656 150 mg administered after a moderate-fat breakfast

Primary Outcome Measures

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

Trial Locations

Locations (1)

CMAX; 🇦🇺 Adelaide, South Australia, Australia