Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
NCT ID: NCT06911320
Last Updated: 2025-09-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
28 participants
INTERVENTIONAL
2025-04-09
2025-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1 - Severe Renal Impairment
Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
A single dose of BEM/RZR will be administered
Group 2 - Severe Hepatic Impairment
Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
A single dose of BEM/RZR will be administered
Group 3 - Matched Healthy Subjects
Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
A single dose of BEM/RZR will be administered
Interventions
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Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
A single dose of BEM/RZR will be administered
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
Yes
Sponsors
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Atea Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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Atea Study Site
Orlando, Florida, United States
Atea Study Site
Tampa, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AT-01B-010
Identifier Type: -
Identifier Source: org_study_id
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