drugset / Trial / NCT03116893
Drug-drug Interaction (DDI) With a P-gp Inhibitor, Organic Anion Transporting Polypeptide OATP-inhibitor, Food Effect
RandomizedCrossoverOpen-labelTreatment
Summary
The primary objective of this trial is to investigate the relative bioavailability of BI 685509 given alone under fasted conditions (Reference, R) compared to the intake after a high fat, high caloric breakfast (Test 1, T1), to combined administration with itraconazole under fasted conditions (Test 2, T2) and to combined administration with rifampin under fasted conditions (Test 3, T3). The secondary objective is the evaluation and comparison of several pharmacokinetic parameters between the treatments.
Timeline
- Start
- 2017-04-19
- Primary completion
- 2017-05-31
- Completion
- 2017-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Avenciguat | Small molecule | — | — |
| Subject | Itraconazole | Small molecule | — | — |
| Subject | Rifampin | Small molecule | — | — |
Indications
No indication recorded.