drugset
drugset / Trial / NCT02256787

Safety, Tolerance, and Pharmacokinetics of Single Rising Oral Doses of BILB 1941 ZW Solution in Healthy Male Subjects, Followed With Bioavailability Comparison of BILB 1941 ZW Tablet and Solution Formulation Administered With or Without Food

NCT02256787 ↗

Phase 1 Completed 56 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

The objective of the current study was to investigate the safety, tolerability, and pharmacokinetics of BILB 1941 ZW following the administration of single rising doses from 5 mg to 300 mg. In addition the bioavailability of the 60 mg dose given fasted and after a high-fat breakfast was to be be investigated

Timeline

Start
2004-01
Primary completion
2004-09
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject BILB-1941 Small molecule 5 mg Oral
Subject BILB-1941 Small molecule 20 mg Oral
Subject BILB-1941 Small molecule 60 mg Oral
Subject BILB-1941 Small molecule 120 mg Oral
Subject BILB-1941 Small molecule 200 mg Oral
Subject BILB-1941 Small molecule 300 mg Oral
Subject BILB-1941 Small molecule 600 mg Oral
Subject BILB-1941 Small molecule 1000 mg Oral
Subject BILB-1941 Small molecule 1500 mg Oral
Subject BILB-1941 Small molecule 2000 mg Oral
Subject BILB-1941 Small molecule 2400 mg Oral
Subject BILB-1941 Small molecule 3000 mg Oral

Indications

No indication recorded.