drugset / Trial / NCT03403439
This Study in Healthy Men Tests How Itraconazole Influences the Amount of BI 1015550 in the Blood
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Itraconazole | Small molecule | 200 mg | Oral |
| Subject | Nerandomilast | Small molecule | 6 mg | Oral |
Indications
No indication recorded.