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

NCT06911320 | Recruiting Phase 1 FDA Drug

• 1 other identifier: AT-01B-010
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy Volunteer Study; Hepatic Impairment; Renal Impairment

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics (PK) of BEM/RZR Maximum plasma concentration (Cmax)

  Day 1

• Pharmacokinetics (PK) of BEM/RZR Area under the plasma concentration-time curve (AUC)

  Day 1

• Pharmacokinetics (PK) of BEM/RZR AUC

  Day 1

Study Arms (3)

Group 1 - Severe Renal Impairment

EXPERIMENTAL

Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

Group 2 - Severe Hepatic Impairment

EXPERIMENTAL

Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

Group 3 - Matched Healthy Subjects

EXPERIMENTAL

Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

Interventions

Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination DRUG

A single dose of BEM/RZR will be administered

Also known as: AT-527 (BEM) and AT-038 (RZR)

Group 1 - Severe Renal Impairment; Group 2 - Severe Hepatic Impairment; Group 3 - Matched Healthy Subjects

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atea Pharmaceuticals, Inc.: lead

Study Sites (2)

Atea Study Site

Orlando, Florida, 32809, United States

RECRUITING

Atea Study Site

Tampa, Florida, 33603, United States

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency

Interventions

AT-511

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Atea Study Clinical Trials Administrator

CONTACT

888-481-1607; ateaclinicaltrials@ateapharma.com

Study Design

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

Study Record Dates

• First Submitted: March 24, 2025
• First Posted: April 4, 2025
• Study Start: April 9, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2025-05

Locations

US (2)