drugset / Trial / NCT01343706
Safety Tolerability and Pharmacokinetic of BI 409306
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of the current study is to investigate the safety and tolerability of BI 409306 in healthy male genotyped volunteers following oral administration of single rising doses. The secondary objectives are: (1) to explore dose proportionality of BI 409306 as immediate release solid oral dosage, (2) to explore the relative bioavailability of BI 409306 when administered as immediate release solid oral dosage compared to oral drinking solution and (3) to compare the safety and pharmacokinetic profiles between two different groups of genotyped subjects.
Timeline
- Start
- 2011-04-01
- Primary completion
- 2011-08-01
- Completion
- 2011-08-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | OSORESNONTRINE | Small molecule | 0.5 mg | Oral |
| Subject | OSORESNONTRINE | Small molecule | 2 mg | Oral |
| Subject | OSORESNONTRINE | Small molecule | 5 mg | Oral |
| Subject | OSORESNONTRINE | Small molecule | 10 mg | Oral |
| Subject | OSORESNONTRINE | Small molecule | 25 mg | Oral |
| Subject | OSORESNONTRINE | Small molecule | 50 mg | Oral |
| Subject | OSORESNONTRINE | Small molecule | 100 mg | Oral |
| Subject | OSORESNONTRINE | Small molecule | 200 mg | Oral |
| Subject | OSORESNONTRINE | Small molecule | 350 mg | Oral |
Indications
No indication recorded.