Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment

Phase 1

Completed

• Conditions: Hepatic Impairment; Healthy
• Interventions: Drug: Favipiravir

• Registration Number: NCT01419457
• Lead Sponsor: MDVI, LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-17
• Study First Posted: 2011-08-18
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	Favipiravir	Normal hepatic function
Group 2	Favipiravir	Mild hepatic impairment
Group 3	Favipiravir	Moderate hepatic impairment
Group 4	Favipiravir	Severe hepatic impairment

Primary Outcome Measures

Name	Time	Method
Cmax of favipiravir	predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 18, 24, 36, 48 hours post-dose on Day 1 and Day 5	The PK parameters for favipiravir and its metabolite in hepatically impaired adult subjects relative to healthy adult subjects matched for age, weight, gender, and race status on Day 1 and on Day 5.
AUC of favipiravir	predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 18, 24, 36, 48 hours post-dose on Day 1 and Day 5	The PK parameters for favipiravir and its metabolite in hepatically impaired adult subjects relative to healthy adult subjects matched for age, weight, gender, and race status on Day 1 and on Day 5.

Secondary Outcome Measures

Name	Time	Method
vital signs	13 days
electrocardiograms [ECGs]	13 days
clinical laboratory assessment	13 days
adverse events [AEs]	13 days
physical examination	13 days

Trial Locations

Locations (2)

University of Miami; 🇺🇸 Miami, Florida, United States

Orlando Clinical Research Center; 🇺🇸 Orlando, Florida, United States