Food Effect Study of CTP-656 in Healthy Male Volunteers

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02680249
• Other study ID #: CP656.1003
• Status: Completed
• Phase: Phase 1
• First received: February 3, 2016
• Last updated: April 29, 2016
• Start date: February 2016
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Concert Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• CTP-656

Locations

Country	Name	City	State
Australia	CMAX	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
Concert Pharmaceuticals

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of CTP-656 in plasma under fed and fasted conditions	Geometric mean ratio of moderate-fat versus low-fat or fasted	96 hours	No