Trials / Completed
CompletedNCT03126578
Open-label, Single Center, Non-randomized, Fixed Sequence Phase 1 Drug-drug Interaction Study With LEO 32731 and Midazolam
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- LEO Pharma · Industry
- Sex
- Male
- Age
- 18 Years – 55 Years
- Healthy volunteers
- Accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | LEO 32731 | LEO 32731 is being developed by LEO Pharma. |
| DRUG | Midazolam | Benzodiazepine |
Timeline
- Start date
- 2017-05-31
- Primary completion
- 2017-10-20
- Completion
- 2017-10-20
- First posted
- 2017-04-24
- Last updated
- 2017-11-14
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT03126578. Inclusion in this directory is not an endorsement.