Oral Bioavailability of GLPG0555 in Different Solid Formulations

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG0555 solid dispersion; Drug: GLPG0555 nanosuspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT01278095

GLPG0555-CL-103

2010-022457-42 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of GLPG0555.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy male
• BMI between 18-30 kg/m², inclusive.

Exclusion criteria

• significantly abnormal platelet function or coagulopathy
• smoking
• drug or alcohol abuse

Trial design

12 participants in 3 patient groups

GLPG0555 solid dispersion, fasting

Experimental group

Description:

50 mg as solid dispersion capsule, in fasting condition

Treatment:

Drug: GLPG0555 solid dispersion

GLPG0555 solid dispersion, fed

Experimental group

Description:

50 mg as solid dispersion capsule, after breakfast

Treatment:

Drug: GLPG0555 solid dispersion

GLPG0555 nanosuspension, fed

Experimental group

Description:

50 mg as nanosuspension, given after breakfast

Treatment:

Drug: GLPG0555 nanosuspension