Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 62
Healthy volunteers: yes

Brief summary:
The primary objective of the current study is to investigate the safety, tolerability and pharmacokinetics of BI 411034 in healthy male volunteers following oral administration of single rising doses.

The secondary objective is to explore dose proportionality of BI 411034 in CYP2C19 (Cytochrome P450) genotyped extensive metabolisers (EM).

Another objective is to compare the safety and pharmacokinetic profiles between two different groups of CYP2C19 genotyped subjects, extensive metabolisers (EM) and poor metabolisers (PM)

Detailed description:

Arms:
arm 1: Solution for oral administration arm 2: Solution for oral administration arm 3: Solution for oral administration arm 4: Solution for oral administration arm 5: Solution for oral administration arm 6: Solution for oral administration arm 7: Solution for oral administration arm 8: Solution for oral administration arm 9: Solution for oral administration

Interventions: intervention 1: BI 411034 intervention 2: Placebo intervention 3: BI 411034 intervention 4: BI 411034 intervention 5: BI 411034 intervention 6: BI 411034 intervention 7: BI 411034 intervention 8: BI 411034 intervention 9: BI 411034
Intervention descriptions: intervention 1: Low dose solution for oral administration intervention 2: Solution for oral administration intervention 3: Medium dose solution for oral administration intervention 4: Low dose solution for oral administration intervention 5: High dose solution for oral administration intervention 6: High dose solution for oral administration intervention 7: Medium dose solution for oral administration intervention 8: High dose solution for oral administration intervention 9: Medium dose solution for oral administration

Protocol document: