First-in-Human Single and Multiple Dose of GLPG1690
Summary
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG1690 given to healthy male subjects, compared to placebo. Also, the safety and tolerability of multiple ascending oral doses of GLPG1690 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 GLPG1690 present in the blood and urine (pharmacokinetics) as well as the reduction of biomarker levels by GLPG1690 in plasma samples (pharmacodynamics) will be characterized compared to placebo. The pharmacokinetics of a solid dosage formulation of GLPG1690 will be compared with those of a liquid dosage formulation of GLPG1690. Also, the potential of cytochrome P450 (CYP)3A4 induction after repeated dosing with GLPG1690 will be explored.
Timeline
- Start
- 2014-06
- Primary completion
- 2014-11
- Completion
- 2014-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ZIRITAXESTAT | Small molecule | 20 mg | Oral |
| Subject | ZIRITAXESTAT | Small molecule | 60 mg | Oral |
| Subject | ZIRITAXESTAT | Small molecule | 150 mg | Oral |
| Subject | ZIRITAXESTAT | Small molecule | 300 mg | Oral |
| Subject | ZIRITAXESTAT | Small molecule | 600 mg | Oral |
| Subject | ZIRITAXESTAT | Small molecule | 1000 mg | Oral |
| Subject | ZIRITAXESTAT | Small molecule | 1500 mg | Oral |
Indications
No indication recorded.