Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment
Completed · Phase 1
Conditions studied: Healthy, Hepatic Impairment
In brief
This study is designed to determine the pharmacokinetics of favipiravir in volunteers with hepatic impairment and in healthy control volunteers.
Key facts
- Study ID
- NCT01419457
- Run by
- MDVI, LLC
- People needed
- 36
- Starts
- 2011-08-01
- Expected to finish
- 2013-02-01
- Last updated by the study team
- 2015-10-22
Who can join
Age: 19 and older, up to 69. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Miami — Miami, Florida, United States
- Orlando Clinical Research Center — Orlando, Florida, United States
Full record on ClinicalTrials.gov
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