Status:
COMPLETED
Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment
Lead Sponsor:
MDVI, LLC
Conditions:
Healthy
Hepatic Impairment
Eligibility:
All Genders
19-69 years
Phase:
PHASE1
Brief Summary
This study is designed to determine the pharmacokinetics of favipiravir in volunteers with hepatic impairment and in healthy control volunteers.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01419457
Start Date
August 1 2011
End Date
February 1 2013
Last Update
October 22 2015
Active Locations (2)
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1
University of Miami
Miami, Florida, United States
2
Orlando Clinical Research Center
Orlando, Florida, United States