Clinical trial NCT01419457: Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Hepatic Impairment
Keywords: Healthy
hepatic impairment
T-705a
Favipiravir
Lead sponsor: MDVI, LLC
Sponsor class: INDUSTRY
First posted: 2011-08-18
Enrollment: 36
Sex: ALL
Minimum age (years): 19
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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 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.

Primary outcomes:
measure: Cmax of favipiravir
timeFrame: 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: AUC of favipiravir
timeFrame: 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 outcomes:
measure: vital signs
timeFrame: 13 days
measure: electrocardiograms [ECGs]
timeFrame: 13 days
measure: clinical laboratory assessment
timeFrame: 13 days
measure: adverse events [AEs]
timeFrame: 13 days
measure: physical examination
timeFrame: 13 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
Study officials:
affiliation: University of Miami
name: Richard A. Preston, MD/MSHP/MBA
role: PRINCIPAL_INVESTIGATOR
References: