Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of GLPG0634 in Healthy Subjects

Galapagos

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: GLPG0634; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01419990

GLPG0634-CL-102

Details and patient eligibility

About

The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses of GLPG0634 given to healthy subjects for 10 days compared to placebo.

During the course of the study, the amount of GLPG0634 present in the blood (pharmacokinetics) as well as the effects of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) will be characterized.

Enrollment: 16 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: Parallel Assignment

Masking: Quadruple Blind

---

16 participants in 2 patient groups, including a placebo group

GLPG0634 capsules

Experimental group

Treatment:

Drug: GLPG0634

Drug: GLPG0634

Placebo capsules

Placebo Comparator group

Treatment:

Drug: Placebo