Healthy, Hepatic Impairment
Conditions
Keywords
Healthy, hepatic impairment, T-705a, Favipiravir
Brief summary
This study is designed to determine the pharmacokinetics of favipiravir in volunteers with hepatic impairment and in healthy control volunteers.
Interventions
DRUGFavipiravir
1200 mg BID for Day 1 + 800 mg BID for Day 2-5
Sponsors
MDVI, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 69 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of favipiravir | 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 | 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
| Measure | Time frame |
|---|---|
| clinical laboratory assessment | 13 days |
| vital signs | 13 days |
| physical examination | 13 days |
| adverse events [AEs] | 13 days |
| electrocardiograms [ECGs] | 13 days |
Countries
United States
Outcome results
None listed