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This study is designed to determine the pharmacokinetics of favipiravir in volunteers with hepatic impairment and in healthy control volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Normal hepatic function |
|
| Group 2 | Experimental | Mild hepatic impairment |
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| Group 3 | Experimental | Moderate hepatic impairment |
|
| Group 4 | Experimental | Severe hepatic impairment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Favipiravir | Drug | 1200 mg BID for Day 1 + 800 mg BID for Day 2-5 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| vital signs | 13 days | |
| electrocardiograms [ECGs] | 13 days | |
| clinical laboratory assessment |
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Inclusion Criteria:
Hepatically impaired groups:
Control group
Exclusion Criteria:
Hepatically impaired groups:
Control group:
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| Name | Affiliation | Role |
|---|---|---|
| Richard A. Preston, MD/MSHP/MBA | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | United States | |||
| Orlando Clinical Research Center |
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| ID | Term |
|---|---|
| C462182 | favipiravir |
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| Favipiravir | Drug | 800 mg BID for Day 1 + 400 mg BID for Day 2-3 |
|
|
| Favipiravir | Drug | 800 mg Single Dose |
|
| 13 days |
| adverse events [AEs] | 13 days |
| physical examination | 13 days |
| Orlando |
| Florida |
| United States |