drugset / Trial / NCT03126578
Open-label, Single Center, Non-randomized, Fixed Sequence Phase 1 Drug-drug Interaction Study With LEO 32731 and Midazolam
NaSingle-groupOpen-labelTreatment
Summary
This is a single center, non-randomized, open-label, fixed sequence study to investigate the effect of multiple oral dosing of LEO 32731 (up-titrated), on CYP3A activity in healthy male subjects using midazolam as a probe CYP3A substrate. The study will be conducted in two seamless parts: Part I - Maximal Tolerated Dose (MTD) Part II - Drug-Drug Interaction with midazolam
Timeline
- Start
- 2017-05-31
- Primary completion
- 2017-10-20
- Completion
- 2017-10-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | LEO 32731 | Unknown | 40 mg | Oral |
| Subject | Midazolam | Small molecule | 2.5 mg | Oral |
Indications
No indication recorded.