Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment

Study Overview
=================
Brief Summary
-----------------
This study is designed to determine the pharmacokinetics of favipiravir in volunteers with hepatic impairment and in healthy control volunteers.

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

Conditions
-----------------
Healthy, Hepatic Impairment

Intervention / Treatment
-----------------
* Drug: Favipiravir
* Drug: Favipiravir
* Drug: Favipiravir


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Normal hepatic function | Drug: Favipiravir<br>* 1200 mg BID for Day 1 + 800 mg BID for Day 2-5<br>* Other names: T-705a;Drug: Favipiravir<br>* 800 mg BID for Day 1 + 400 mg BID for Day 2-3<br>* Other names: T-705a;|
| Experimental: Group 2<br>Mild hepatic impairment | Drug: Favipiravir<br>* 1200 mg BID for Day 1 + 800 mg BID for Day 2-5<br>* Other names: T-705a;|
| Experimental: Group 3<br>Moderate hepatic impairment | Drug: Favipiravir<br>* 1200 mg BID for Day 1 + 800 mg BID for Day 2-5<br>* Other names: T-705a;|
| Experimental: Group 4<br>Severe hepatic impairment | Drug: Favipiravir<br>* 800 mg BID for Day 1 + 400 mg BID for Day 2-3<br>* Other names: T-705a;Drug: Favipiravir<br>* 800 mg Single Dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| vital signs |  | 13 days | 
| electrocardiograms [ECGs] |  | 13 days | 
| clinical laboratory assessment |  | 13 days | 
| adverse events [AEs] |  | 13 days | 
| physical examination |  | 13 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy, hepatic impairment, T-705a, Favipiravir