Study of Bemnifosbuvir in Subjects With Normal and Impaired Hepatic Function

Last updated: July 29, 2024
Sponsor: Atea Pharmaceuticals, Inc.
Overall Status: Completed

Phase

1

Condition

N/A

Treatment

Bemnifosbuvir (BEM)

Clinical Study ID

NCT05724693
AT-03A-010
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir After a Single Dose

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must agree to use two methods of birth control from Screening through 90 days afteradministration of the last dose of study drug

  • Females must have a negative pregnancy test at Screening and prior to dosing

  • BMI of 18.5 to 42.0 kg/m2

  • Willing to comply with the study requirements and to provide written informedconsent

Subjects with Normal Hepatic Function (Groups 3 and 5):

  • Medically healthy, in the opinion of an Investigator

  • Must match by gender, age (± 10 years), and BMI (± 20%) to the pooled mean values ofsubjects with hepatic impairment

Hepatic Impaired Subjects (Groups 1, 2, and 4):

  • Considered stable for at least 1 month prior to Screening, as per the judgement ofan Investigator

  • When applicable, presence of mild hepatic impairment (Child-Pugh Class A: score of 5to 6), moderate hepatic impairment (Child-Pugh Class B: score of 7 to 9) or severehepatic impairment (Child-Pugh Class C: score of 10 to 15). Hepatic impairmentshould be stable for at least 1 month prior to Screening

Exclusion

Exclusion Criteria:

  • Pregnant or breastfeeding

  • Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19

  • Abuse of alcohol or drugs

  • Use of other investigational drugs within 28 days of dosing

  • Other clinically significant medical conditions or laboratory abnormalities

Hepatic Impaired Subjects (Groups 1, 2, and 4):

  • Currently undergoing any method of dialysis

  • History of liver transplant

  • Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c (HbA1c) > 10%

  • Evidence of hepatic carcinoma presence at Screening

Study Design

Total Participants: 39
Treatment Group(s): 1
Primary Treatment: Bemnifosbuvir (BEM)
Phase: 1
Study Start date:
January 30, 2023
Estimated Completion Date:
April 23, 2024

Connect with a study center

  • Atea Study Site Orlando Clinical Research Center

    Orlando, Florida 32809
    United States

    Site Not Available

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