NCT03019991

Safety, Tolerability and Pharmacokinetics of Danoprevir/r in Healthy Volunteers China

A Study on Safety, Tolerability and Pharmacokinetics of Ritonavir-boosted Danoprevir in Single and Multiple Doses in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Ascletis Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the Pharmacokinetics of Danoprevir in single dose (100mg QD on day 1, day 4 and day 14) and Ritonavir-boosted Danoprevir (100mg QD on day 4 and day 14) in single and multiple doses (100mg BID on day 5 -day 13) in healthy volunteers.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Danoprevir	Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13
DRUG	Ritonavir	Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13
DRUG	Placebo	ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13

Timeline

• Start date: 2015-10-01
• Primary completion: 2015-11-01
• Completion: 2015-11-01
• First posted: 2017-01-13
• Last updated: 2017-01-13