drugset / Trial / NCT02253927

Dose Escalation Study of Pharmacokinetics, Safety and Tolerability After Single Dose Administration of BILR 355 (SDS) Plus Low-dose Ritonavir in Healthy Volunteers

NCT02253927

Phase 1 Completed 48 enrolled Boehringer Ingelheim
NaSingle-groupOpen-labelTreatment

Summary

The primary objective was to explore the relative bioavailability of increasing doses of BILR 355 BS, as a sodium dodecyl sulfate-containing solid formulation (SDS), in combination with ritonavir 100 mg and to explore the dose-concentration proportionality of increasing doses. A secondary objective was to explore the effect of food on the pharmacokinetics of BILR 355 (SDS)

Timeline

Start
2006-05
Primary completion
2006-08
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject BILR 355 Small molecule 225 mg Oral
Subject BILR 355 Small molecule 450 mg Oral
Background Ritonavir Other / unclassified 100 mg Oral

Indications

No indication recorded.