First-in-Human Single and Multiple Dose of GLPG1205
Summary
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1205 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1205 given to healthy male subjects daily for 14 days compared to placebo, will be evaluated. Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG1205 present in the blood and urine (pharmacokinetics) as well as the receptor occupancy by GLPG1205 in blood samples (pharmacodynamics) will be characterized compared to placebo. Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1205 will be explored.
Timeline
- Start
- 2013-06
- Primary completion
- 2013-09
- Completion
- 2013-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GLPG1205 | Small molecule | 10 mg | Oral |
| Subject | GLPG1205 | Small molecule | 100 mg | Oral |
| Subject | GLPG1205 | Small molecule | 400 mg | Oral |
| Subject | GLPG1205 | Small molecule | 800 mg | Oral |
Indications
No indication recorded.