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Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment

NCT01419457 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2015-10-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • MDVI, LLC

    lead INDUSTRY

Principal Investigators

  • Richard A. Preston, MD/MSHP/MBA · University of Miami

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01419457 on ClinicalTrials.gov