Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 25
Healthy volunteers: yes

Brief summary:
The objective of the current study is to evaluate the effect of once daily itraconazole on the pharmacokinetics of BI 409306 in poor (PM) and extensive metabolisers (EM) of CYP2C19.

Detailed description:

Arms:
arm 1: Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were:

* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. arm 2: Participants who were poor metabolisers received two treatments in a randomised order, the treatments were:

* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).
* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1. arm 3: Participants who were extensive metabolisers received two treatments in a randomised order, the treatments were:

* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1). arm 4: Participants who were poor metabolisers received two treatments in a randomised order, the treatments were:

* Test treatment (2 capsules of 100 mg itraconazole taken orally twice daily on day -3 (loading dose) and once daily on day -2 to day 2, plus 1 tablet of 25 mg BI 409306 taken orally as a single dose 1 hour after the itraconazole administration on day 1.
* Reference (ref) treatment (1 single tablet of 25 mg BI 409306 taken orally on day 1).

Interventions: intervention 1: BI 409306 intervention 2: Itraconazole
Intervention descriptions: intervention 1: Oral single dose of BI 409306 intervention 2: Oral dose, twice daily on Day -3, once daily on Day -2 to Day 2 of Itraconazole

Protocol document: