drugset / Trial / NCT03116893

Drug-drug Interaction (DDI) With a P-gp Inhibitor, Organic Anion Transporting Polypeptide OATP-inhibitor, Food Effect

NCT03116893

Phase 1 Completed 15 enrolled Boehringer Ingelheim
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

EvaluationDrugModalityDoseRoute
Subject Avenciguat Small molecule
Subject Itraconazole Small molecule
Subject Rifampin Small molecule

Indications

No indication recorded.