Conditions: Healthy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 80
Healthy volunteers: yes

Brief summary:
The primary objective of the current study is to investigate the safety and tolerability of BI 113608 in healthy male volunteers following oral administration of single rising doses.

A secondary objective is the exploration of the pharmacokinetics of BI 113608 after single dosing.

Detailed description:

Arms:
arm 1: Powder for oral solution arm 2: Powder for oral solution arm 3: Powder for oral solution arm 4: Powder for oral solution arm 5: Powder for oral solution arm 6: Powder for oral solution arm 7: Powder for oral solution arm 8: Powder for oral solution arm 9: Powder for oral solution arm 10: Powder for oral solution arm 11: Powder for oral solution

Interventions: intervention 1: BI 113608 intervention 2: BI 113608 intervention 3: BI 113608 intervention 4: BI 113608 intervention 5: Placebo intervention 6: BI 113608 intervention 7: BI 113608 intervention 8: BI 113608 intervention 9: BI 113608 intervention 10: BI 113608 intervention 11: BI 113608
Intervention descriptions: intervention 1: Low dose powder for oral solution intervention 2: High dose powder for oral solution intervention 3: Medium dose powder for oral solution intervention 4: Low dose powder for oral solution intervention 5: Powder for oral solution intervention 6: Low dose powder for oral solution intervention 7: High dose powder for oral solution intervention 8: High dose powder for oral solution intervention 9: Medium dose powder for oral solution intervention 10: Medium dose powder for oral solution intervention 11: Low dose powder for oral solution

Protocol document: