Food Effect Study of CTP-656 in Healthy Male Volunteers

Concert Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: CTP-656

Study type: Interventional

Funder types: Industry

Identifiers

NCT02680249

CP656.1003

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 3 patient groups

CTP-656 Fed, low fat

Experimental group

Description:

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

Treatment:

Drug: CTP-656

CTP-656 Fasted

Experimental group

Description:

Single dose of CTP-656 150 mg administered fasted

Treatment:

Drug: CTP-656

CTP-656 Fed, high fat

Experimental group

Description:

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

Treatment:

Drug: CTP-656