This study is designed to determine the pharmacokinetics of favipiravir in volunteers with hepatic impairment and in healthy control volunteers.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
36
1200 mg BID for Day 1 + 800 mg BID for Day 2-5
800 mg BID for Day 1 + 400 mg BID for Day 2-3
800 mg Single Dose
University of Miami
Miami, Florida, United States
Orlando Clinical Research Center
Orlando, Florida, United States
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.
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
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.
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
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
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