Oral Bioavailability of Two Solid Formulations of GLPG0634

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 200 mg GLPG0634 as tablets, fasted; Drug: 200 mg GLPG0634 as tablets, fed; Drug: 200 mg GLPG0634 as capsules, fasted

Study type: Interventional

Funder types: Industry

Identifiers

NCT01915667

GLPG0634-CL-107

Details and patient eligibility

About

The purpose of the study is to evaluate the amount of compound present in the blood (relative bioavailability) after a single administration of GLPG0634 as a tablet versus a capsule in fasted conditions in male healthy subjects.

Also, the effect of food on the bioavailability of the tablet formulation will be studied as well as the safety and tolerability of single oral doses of GLPG0634 given either as capsule or tablet.

Enrollment: 12 patients

Sex: Male

Ages: 40 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male, age 40-60 years
• BMI between 18-30 kg/m2

Exclusion criteria

• Any condition that might interfere with the procedures or tests in this study
• Drug or alcohol abuse
• Smoking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 3 patient groups

GLPG0634 capsule fasted

Experimental group

Description:

Single dose of GLPG0634 as capsules in fasted condition

Treatment:

Drug: 200 mg GLPG0634 as capsules, fasted

GLPG0634 tablet fasted

Experimental group

Description:

Single dose of GLPG0634 as tablets in fasted condition

Treatment:

Drug: 200 mg GLPG0634 as tablets, fasted

GLPG0634 tablet fed

Active Comparator group

Description:

Single dose of GLPG0634 as tablets in fed condition

Treatment:

Drug: 200 mg GLPG0634 as tablets, fed