GLPG0259 Solid Formulation Bioavailability and Food Effect

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG0259 solution; Drug: GLPG0259

Study type: Interventional

Funder types: Industry

Identifiers

NCT01024517

GLPG0259-CL-103

Details and patient eligibility

About

The purpose of the study is to compare the pharmacokinetics of GLPG0259 as a solid dosage formulation (with and without food)and an oral solution, and to assess its safety and tolerability.

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, inclusive.

Exclusion criteria

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

Trial design

12 participants in 3 patient groups

Single oral dose, solution

Experimental group

Treatment:

Drug: GLPG0259 solution

Single oral dose, solid, fasted

Experimental group

Treatment:

Drug: GLPG0259

Single oral dose, solid, fed.

Experimental group

Treatment:

Drug: GLPG0259