Oral Bioavailability of Solid Formulation of GLPG1205 With and Without Food

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: 100 mg GLPG1205

Study type: Interventional

Funder types: Industry

Identifiers

NCT02143856

2013-004771-12 (EudraCT Number)

GLPG1205-CL-102

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 oral administration of GLPG1205 given as a capsule formulation in fasted versus fed conditions in male healthy subjects.

Also, the safety and tolerability of a single oral dose of GLPG1205 given as a capsule formulation under fasted and fed conditions will be assessed.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male, age 18-50 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 2 patient groups

100 mg GLPG1205 fasted

Experimental group

Description:

Single dose of 100 mg GLPG1205 as two capsules of 50 mg after an overnight fast

Treatment:

Drug: 100 mg GLPG1205

100 mg GLPG1205 fed

Experimental group

Description:

Single dose of 100 mg GLPG1205 as two capsules of 50 mg exactly 30 minutes after the start of a high-fat, high-calorie breakfast

Treatment:

Drug: 100 mg GLPG1205