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

Phase 1

Not yet recruiting

• Conditions: Healthy Volunteer Study; Hepatic Impairment; Renal Impairment
• Interventions: Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

• Registration Number: NCT06911320
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-24
• Study First Submitted QC: 2025-03-28
• Last Update Submitted: 2025-03-28
• Study Start: 2025-04
• Study First Posted: 2025-04-04
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1 - Severe Renal Impairment	Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination	Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
Group 2 - Severe Hepatic Impairment	Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination	Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
Group 3 - Matched Healthy Subjects	Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination	Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Atea Study Site; 🇺🇸 Tampa, Florida, United States