drugset / Trial / NCT01581684
Safety Tolerability and Pharmacokinetic of BI 411034
RandomizedSingle-groupSingle-blindTreatment
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)
Timeline
- Start
- 2012-04-01
- Primary completion
- 2012-08-01
- Completion
- 2012-08-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BI 411034 | Unknown | — | Oral |
Indications
No indication recorded.