Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function

April 8, 2026 updated by: Atea Pharmaceuticals, Inc.

A Phase 1, Open-Label, Parallel-Group, Single-Dose Study to Evaluate the Safety and Pharmacokinetics of Bemnifosbuvir and Ruzasvir Administered as a Fixed-Dose Combination in Adult Participants With Severe Renal or Hepatic Impairment in Comparison to Healthy Participants

To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Must agree to use two methods of birth control from Screening through 90 days after administration 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 43.0 kg/m2
  • Willing to comply with the study requirements and to provide written informed consent

Renal Impaired Subjects (Group 1):

  • Considered stable in the judgement of an Investigator
  • Presence of severe renal impairment or kidney failure (as defined by eGFR< 30 mL/ min)

Hepatic Impaired Subjects (Group 2):

  • Considered stable for at least 1 month prior to Screening, as per the judgement of an Investigator
  • Presence of severe hepatic impairment (Child-Pugh Class C: score of 10 to 15).

Subjects with Normal Hepatic and Renal Function (Group 3):

  • Medically healthy, in the opinion of an Investigator
  • Must match by gender, age (± 10 years), and BMI (within 20%) to the pooled mean values of subjects with severe renal and hepatic impairment

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Infected with hepatitis B virus, hepatitis C virus or HIV
  • Abuse of alcohol or drugs
  • Use of other investigational drugs within 28 days of dosing
  • Other clinically significant medical conditions or laboratory abnormalities

Renal and Hepatic Impaired Subjects (Group 1 and 2):

  • Presence of poorly controlled Type 1 or Type 2 diabetes as defined by Hemoglobin A1c > 10%
  • Undergoing any method of dialysis
  • Subjects requiring treatment for hepatic impairment or other chronic disease must be on a stable treatment plan

Renal Impaired Subjects (Group 1):

  • History of renal transplant
  • Concurrent use of medications known to affect the elimination of serum creatinine

Hepatic Impaired Subjects (Group 2):

  • History of liver transplant
  • Evidence of hepatic carcinoma presence at Screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1 - Severe Renal Impairment
Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
A single dose of BEM/RZR will be administered
Other Names:
  • AT-527 (BEM) and AT-038 (RZR)
Experimental: Group 2 - Severe Hepatic Impairment
Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
A single dose of BEM/RZR will be administered
Other Names:
  • AT-527 (BEM) and AT-038 (RZR)
Experimental: Group 3 - Matched Healthy Subjects
Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
A single dose of BEM/RZR will be administered
Other Names:
  • AT-527 (BEM) and AT-038 (RZR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK) of BEM/RZR Maximum plasma concentration (Cmax)
Time Frame: Day 1
Day 1
Pharmacokinetics (PK) of BEM/RZR Area under the plasma concentration-time curve (AUC)
Time Frame: Day 1
Day 1
Pharmacokinetics (PK) of BEM/RZR AUC
Time Frame: Day 1
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atea Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

March 24, 2025

First Submitted That Met QC Criteria

March 28, 2025

First Posted (Actual)

April 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-01B-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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