drugset / Trial / NCT03403439

This Study in Healthy Men Tests How Itraconazole Influences the Amount of BI 1015550 in the Blood

NCT03403439

Phase 1 Completed 16 enrolled Boehringer Ingelheim
NaSingle-groupOpen-labelTreatment

Summary

The primary objective of this trial is to investigate whether and to what extent co-administration of multiple doses of itraconazole affect single dose pharmacokinetics of BI1015550, i.e. to compare the relative bioavailability of 6 mg BI 1015550 when given alone (reference, treatment R) to the relative bioavailability of 6 mg of BI 1015550 given on the 4th day of a 12-day-treatment with itraconazole (test, treatment T) following oral administration in healthy male subjects.

Timeline

Start
2018-05-03
Primary completion
2018-07-20
Completion
2018-07-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Itraconazole Small molecule 200 mg Oral
Subject Nerandomilast Small molecule 6 mg Oral

Indications

No indication recorded.