drugset
drugset / Trial / NCT02254707

Evaluation of the Antiviral Pharmacodynamic Effect, Safety, and Pharmacokinetics of Escalating Doses of BILB 1941 ZW to Patients With Chronic Hepatitis C Genotype 1 Virus Infection

NCT02254707 ↗

Phase 1/2 Completed 96 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

To assess the antiviral effect, safety and pharmacokinetics of rising doses of 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, 100 mg, 150 mg, 200 mg, 300 mg, 450 mg, 650 mg, 900 mg oral BILB 1941 ZW administered Q8H in a polyethyleneglycol 400 (PEG 400): distilled water: Tromethamine (TRIS) drinking solution for five days to patients with chronic HCV genotype 1 infection

Timeline

Start
2004-07
Primary completion
2006-04
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject BILB-1941 Small molecule 10 mg Oral
Subject BILB-1941 Small molecule 20 mg Oral
Subject BILB-1941 Small molecule 40 mg Oral
Subject BILB-1941 Small molecule 60 mg Oral
Subject BILB-1941 Small molecule 80 mg Oral
Subject BILB-1941 Small molecule 100 mg Oral
Subject BILB-1941 Small molecule 150 mg Oral
Subject BILB-1941 Small molecule 200 mg Oral
Subject BILB-1941 Small molecule 300 mg Oral
Subject BILB-1941 Small molecule 450 mg Oral
Subject BILB-1941 Small molecule 650 mg Oral
Subject BILB-1941 Small molecule 900 mg Oral

Indications

chronic hepatitis C virus infection