drugset / Trial / NCT02268760

Safety, Tolerance, and Pharmacokinetics of BILN 2061 ZW in Healthy Male Subjects, Combined With Preliminary Evaluation of Food Effect

NCT02268760 ↗

Phase 1 Completed 103 enrolled Boehringer Ingelheim
RandomizedParallel-groupDouble-blindTreatment

Summary

To assess the safety, tolerance and pharmacokinetics of 5 mg to 2400 mg BILN 2061 ZW 1. In rising single doses 2. With and without a 64 g fat breakfast at one selected dose

Timeline

Start
2001-06
Primary completion
2001-09
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject CILUPREVIR Small molecule 5 mg Oral
Subject CILUPREVIR Small molecule 20 mg Oral
Subject CILUPREVIR Small molecule 60 mg Oral
Subject CILUPREVIR Small molecule 100 mg Oral
Subject CILUPREVIR Small molecule 200 mg Oral
Subject CILUPREVIR Small molecule 400 mg Oral
Subject CILUPREVIR Small molecule 600 mg Oral
Subject CILUPREVIR Small molecule 800 mg Oral
Subject CILUPREVIR Small molecule 1000 mg Oral
Subject CILUPREVIR Small molecule 1200 mg Oral
Subject CILUPREVIR Small molecule 1500 mg Oral
Subject CILUPREVIR Small molecule 2000 mg Oral
Subject CILUPREVIR Small molecule 2400 mg Oral

Indications

No indication recorded.