Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment

NCT01419457 | Completed Phase 1 DMC

• 1 other identifier: T705aUS109
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

Brief Summary

This study is designed to determine the pharmacokinetics of favipiravir in volunteers with hepatic impairment and in healthy control volunteers.

Conditions

Healthy; Hepatic Impairment

Keywords

Healthy; hepatic impairment; T-705a; Favipiravir

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• vital signs

  13 days

• electrocardiograms [ECGs]

  13 days

• clinical laboratory assessment

  13 days

• adverse events [AEs]

  13 days

• physical examination

  13 days

Study Arms (4)

Group 1

EXPERIMENTAL

Normal hepatic function

Drug: Favipiravir

Group 2

EXPERIMENTAL

Mild hepatic impairment

Drug: Favipiravir

Group 3

EXPERIMENTAL

Moderate hepatic impairment

Drug: Favipiravir

Group 4

EXPERIMENTAL

Severe hepatic impairment

Drug: Favipiravir

Interventions

Favipiravir DRUG

1200 mg BID for Day 1 + 800 mg BID for Day 2-5

Also known as: T-705a

Group 1; Group 2; Group 3

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• MDVI, LLC: lead

Study Sites (2)

University of Miami

Miami, Florida, United States

Location

Orlando Clinical Research Center

Orlando, Florida, United States

Location

MeSH Terms

Interventions

favipiravir

Study Officials

• Richard A. Preston, MD/MSHP/MBA

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2011
• First Posted: August 18, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: October 22, 2015

Record last verified: 2015-10

Locations

US (2)