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Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01419457
First Posted: August 18, 2011
Last Update Posted: October 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MDVI, LLC
  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
Intervention Model: Parallel Assignment
Masking: None (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 MDVI, LLC:

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 ]
    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 ]
    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 ]
  • electrocardiograms [ECGs] [ Time Frame: 13 days ]
  • clinical laboratory assessment [ Time Frame: 13 days ]
  • adverse events [AEs] [ Time Frame: 13 days ]
  • physical examination [ Time Frame: 13 days ]

Enrollment: 36
Study Start Date: August 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   19 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419457


Locations
United States, Florida
University of Miami
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
Sponsors and Collaborators
MDVI, LLC
Investigators
Principal Investigator: Richard A. Preston, MD/MSHP/MBA University of Miami
  More Information

Responsible Party: MDVI, LLC
ClinicalTrials.gov Identifier: NCT01419457     History of Changes
Other Study ID Numbers: T705aUS109
First Submitted: August 10, 2011
First Posted: August 18, 2011
Last Update Posted: October 22, 2015
Last Verified: October 2015

Keywords provided by MDVI, LLC:
Healthy
hepatic impairment
T-705a
Favipiravir

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases