Bioavailability Study of Prodrug of GLPG0187 in Healthy Volunteers

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG0187 prodrug

Study type: Interventional

Funder types: Industry

Identifiers

NCT01580644

GLPG0187-CL-104

Details and patient eligibility

About

The purpose of this study is to evaluate the amount of GLPG0187 present in the blood (pharmacokinetics) after a single oral dose of the prodrug of GLPG0187 given to healthy subjects.

Two formulations of the GLPG0187 prodrug will be compared, as well as the effect of food and dose proportionality of the best formulation.

Furthermore, during the course of the study, safety and tolerability will be characterized.

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: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Period 1: formulation 1 oral solution

Experimental group

Treatment:

Drug: GLPG0187 prodrug

Period 2: formulation 2 capsule

Experimental group

Treatment:

Drug: GLPG0187 prodrug

Period 3: Selected formulation + food

Experimental group

Treatment:

Drug: GLPG0187 prodrug

Period 4: Selected formulation at higher dose

Experimental group

Treatment:

Drug: GLPG0187 prodrug