drugset / Trial / NCT01343706

Safety Tolerability and Pharmacokinetic of BI 409306

NCT01343706

Phase 1 Completed 80 enrolled Boehringer Ingelheim
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

EvaluationDrugModalityDoseRoute
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.