drugset
drugset / Trial / NCT02184338

Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BIRB 1017 BS as a Solution in PEG 400 / 26% Ethanol Administered to Healthy Male Subjects

NCT02184338 ↗

Phase 1 Completed 48 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

Study to assess safety, tolerability and pharmacokinetics of BIRB 1017 BS in single rising oral doses of 5 to 800 mg in a polyethylene glycol 400 (PEG 400) / 26% ethanol solution in healthy male subjects

Timeline

Start
2004-08
Primary completion
2004-11
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject BIBR 1017 BS Unknown 5 mg Oral
Subject BIBR 1017 BS Unknown 25 mg Oral
Subject BIBR 1017 BS Unknown 100 mg Oral
Subject BIBR 1017 BS Unknown 250 mg Oral
Subject BIBR 1017 BS Unknown 500 mg Oral
Subject BIBR 1017 BS Unknown 800 mg Oral

Indications

No indication recorded.