Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419457
• Other study ID #: T705aUS109
• Status: Completed
• Phase: Phase 1
• First received: August 10, 2011
• Last updated: October 20, 2015
• Start date: August 2011
• Est. completion date: February 2013

Study information

• Verified date: October 2015
• Source: MDVI, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 69 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Hepatic Impairment
• Liver Diseases

Intervention

Drug:
• Favipiravir
1200 mg BID for Day 1 + 800 mg BID for Day 2-5
• Favipiravir
800 mg BID for Day 1 + 400 mg BID for Day 2-3
• Favipiravir
800 mg Single Dose

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
MDVI, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of favipiravir	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.	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	No
Primary	AUC of favipiravir	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.	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	No
Secondary	vital signs		13 days	Yes
Secondary	electrocardiograms [ECGs]		13 days	Yes
Secondary	clinical laboratory assessment		13 days	Yes
Secondary	adverse events [AEs]		13 days	Yes
Secondary	physical examination		13 days	Yes