Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment - Full Text View

Sponsor:	FujiFilm Pharmaceuticals U.S.A., Inc.
Information provided by (Responsible Party):	FujiFilm Pharmaceuticals U.S.A., Inc.
ClinicalTrials.gov Identifier:	NCT01419457

Purpose

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

Condition	Intervention	Phase
Healthy Hepatic Impairment	Drug: Favipiravir	Phase 1

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

Further study details as provided by FujiFilm Pharmaceuticals U.S.A., Inc.:

Primary Outcome Measures:

Cmax of favipiravir [ Time Frame: 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 ] [ Designated as safety issue: No ]
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 [ Time Frame: 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 ] [ Designated as safety issue: No ]
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:

vital signs [ Time Frame: 13 days ] [ Designated as safety issue: Yes ]
electrocardiograms [ECGs] [ Time Frame: 13 days ] [ Designated as safety issue: Yes ]
clinical laboratory assessment [ Time Frame: 13 days ] [ Designated as safety issue: Yes ]
adverse events [AEs] [ Time Frame: 13 days ] [ Designated as safety issue: Yes ]
physical examination [ Time Frame: 13 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	36
Study Start Date:	August 2011
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Group 1 Normal hepatic function	Drug: Favipiravir 1200 mg BID for Day 1 + 800 mg BID for Day 2-5 Other Name: T-705a Drug: Favipiravir 800 mg BID for Day 1 + 400 mg BID for Day 2-3 Other Name: T-705a
Experimental: Group 2 Mild hepatic impairment	Drug: Favipiravir 1200 mg BID for Day 1 + 800 mg BID for Day 2-5 Other Name: T-705a
Experimental: Group 3 Moderate hepatic impairment	Drug: Favipiravir 1200 mg BID for Day 1 + 800 mg BID for Day 2-5 Other Name: T-705a
Experimental: Group 4 Severe hepatic impairment	Drug: Favipiravir 800 mg BID for Day 1 + 400 mg BID for Day 2-3 Other Name: T-705a Drug: Favipiravir 800 mg Single Dose

Eligibility

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419457

Locations

United States, Florida
University of Miami
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States

Sponsors and Collaborators

FujiFilm Pharmaceuticals U.S.A., Inc.

Investigators

Principal Investigator:

Richard A. Preston, MD/MSHP/MBA

University of Miami

More Information

No publications provided

Responsible Party:	FujiFilm Pharmaceuticals U.S.A., Inc.
ClinicalTrials.gov Identifier:	NCT01419457 History of Changes
Other Study ID Numbers:	T705aUS109
Study First Received:	August 10, 2011
Last Updated:	May 21, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by FujiFilm Pharmaceuticals U.S.A., Inc.:

Healthy
hepatic impairment
T-705a
Favipiravir

Additional relevant MeSH terms:

Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2012