Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-02-28

Brief Summary

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

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Detailed Description

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Conditions

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Healthy Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Group 1

Normal hepatic function

Group Type EXPERIMENTAL

Favipiravir

Intervention Type DRUG

1200 mg BID for Day 1 + 800 mg BID for Day 2-5

Favipiravir

Intervention Type DRUG

800 mg BID for Day 1 + 400 mg BID for Day 2-3

Group 2

Mild hepatic impairment

Group Type EXPERIMENTAL

Favipiravir

Intervention Type DRUG

1200 mg BID for Day 1 + 800 mg BID for Day 2-5

Group 3

Moderate hepatic impairment

Group Type EXPERIMENTAL

Favipiravir

Intervention Type DRUG

1200 mg BID for Day 1 + 800 mg BID for Day 2-5

Group 4

Severe hepatic impairment

Group Type EXPERIMENTAL

Favipiravir

Intervention Type DRUG

800 mg BID for Day 1 + 400 mg BID for Day 2-3

Favipiravir

Intervention Type DRUG

800 mg Single Dose

Interventions

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Favipiravir

1200 mg BID for Day 1 + 800 mg BID for Day 2-5

Intervention Type DRUG

Favipiravir

800 mg BID for Day 1 + 400 mg BID for Day 2-3

Intervention Type DRUG

Favipiravir

800 mg Single Dose

Intervention Type DRUG

Other Intervention Names

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T-705a T-705a

Eligibility Criteria

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Inclusion Criteria

* Hepatically impaired groups:

* Agree to doctor approved birth control methods from Day 1 until 3 months following the final dose of study drug.
* Have mild hepatic impairment (Child-Pugh Clinical Assessment Score Grade A, score 5 6) or moderate hepatic impairment (Child-Pugh Clinical Assessment Score Grade B, score 7-9) or severe hepatic impairment (Child-Pugh Clinical Assessment Score Grade C, score 10-15);
* Control group

* Agree to doctor approved birth control methods from Day 1 until 3 months following the final dose of study drug.
* Healthy as determined by medical history, physical exam, vital signs, ECGs, and clinical laboratory tests.

Exclusion Criteria

* Hepatically impaired groups:

* Have used any drugs known to significantly affect hepatic metabolism within 28 days, or is unable or unwilling to forgo the use of such products throughout the study;
* Have any acute or unstable condition or disease, other than impaired hepatic function, as determined by medical history, physical exam, ECG and clinical laboratory tests;
* Known ongoing alcohol and/or drug abuse within 1 month
* Any evidence of progressive worsening liver function disease as indicated by laboratory values;
* Have had an acute flare of hepatitis A or B within 6 months;
* Have acute, fulminant alcoholic hepatitis, determined either clinically or by histology;
* Have a history of hepatoma or metastatic disease of the liver;
* Control group:

* Have used any drugs known to significantly affect hepatic metabolism within 28 days, or is unable or unwilling to forgo the use of such products throughout the study;
* Have a history or presence of clinically cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, hepatic, immunologic, neurologic, oncologic, psychiatric, pulmonary, or renal disease or any other condition.

Minimum Eligible Age

19 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes