NCT01419457

Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment

A Phase I, Open-Label, Parallel-Group, Multiple-Dose Study to Determine the Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment and in Healthy Control Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: MDVI, LLC · Industry
• Sex: All
• Age: 19 Years – 69 Years
• Healthy volunteers: Accepted

Summary

This study is designed to determine the pharmacokinetics of favipiravir in volunteers with hepatic impairment and in healthy control volunteers.

Conditions

• Healthy
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Favipiravir	1200 mg BID for Day 1 + 800 mg BID for Day 2-5
DRUG	Favipiravir	800 mg BID for Day 1 + 400 mg BID for Day 2-3
DRUG	Favipiravir	800 mg Single Dose

Timeline

• Start date: 2011-08-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2011-08-18
• Last updated: 2015-10-22

Locations

2 sites across 1 country: United States