Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment

• Register: ClinicalTrials.gov
• Last refreshed on: 25 March 2013
• Main ID: NCT01419457
• Date of registration: 10/08/2011
• Primary sponsor: FujiFilm Pharmaceuticals U.S.A., Inc.
• Public title: Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment
• Scientific 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
• Date of first enrolment: August 2011
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01419457
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Countries of recruitment

United States

Contacts

• Name: Richard A. Preston, MD/MSHP/MBA
• Affiliation: University of Miami

Key inclusion & exclusion 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.



Age minimum: 19 Years
Age maximum: 69 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Hepatic Impairment

Intervention(s)

Drug: Favipiravir

Primary Outcome(s)

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]

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]

Secondary Outcome(s)

adverse events [AEs] [Time Frame: 13 days]

clinical laboratory assessment [Time Frame: 13 days]

electrocardiograms [ECGs] [Time Frame: 13 days]

physical examination [Time Frame: 13 days]

vital signs [Time Frame: 13 days]

Secondary ID(s)

T705aUS109

Source(s) of Monetary Support

Please refer to primary and secondary sponsors