Healthy Volunteer StudyPhase 1NCT06911320
Study of Bemnifosbuvir/Ruzasvir as a Fixed-dose Combination in Subjects With Normal or Severely Impaired Renal or Hepatic Function
A Phase 1 study testing Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination in people with Healthy Volunteer Study and Hepatic Impairment, run by Atea Pharmaceuticals, Inc. at 2 sites in United States.
Trial summary
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study, Hepatic Impairment, Renal Impairment
- What is being tested?
- Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Apr 2025to 30 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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):
Show all 15Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Atea Study Site
Orlando, Florida, 32809
Atea Study Site
Tampa, Florida, 33603
About this study
Official title: 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
- Being tested
- Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combinationDrug
Also called AT-527 (BEM) and AT-038 (RZR)
A single dose of BEM/RZR will be administered
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Severe Renal Impairment | Experimental | Single dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination Receives: 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 Receives: 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 Receives: Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of BEM/RZR Maximum plasma concentration (Cmax)
Measured: Day 1
Pharmacokinetics (PK) of BEM/RZR Area under the plasma concentration-time curve (AUC)
Measured: Day 1
Pharmacokinetics (PK) of BEM/RZR AUC
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start9 Apr 2025
- Primary completion30 Apr 2026
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atea Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911320
- Sponsor's protocol ID
- AT-01B-010
- Status last verified
- May 2025
- First submitted
- 24 Mar 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06911320
- Acronym / sponsor ID
- AT-01B-010
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 4 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To Assess the Effect of Severe Hepatic or Renal Impairment on the Pharmacokinetics of Bemnifosbuvir/Ruzasvir After a Single Dose
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Severe Renal Impairment | Experimental | Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combinationSingle dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination |
| Group 2 - Severe Hepatic Impairment | Experimental | Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combinationSingle dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination |
| Group 3 - Matched Healthy Subjects | Experimental | Drug: Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combinationSingle dose Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Considered stable in the judgement of an Investigator
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combinationAlso: AT-527 (BEM) and AT-038 (RZR)A single dose of BEM/RZR will be administered | Drug | Group 1 - Severe Renal Impairment, Group 2 - Severe Hepatic Impairment, Group 3 - Matched Healthy Subjects |
Primary outcome
Pharmacokinetics (PK) of BEM/RZR Maximum plasma concentration (Cmax)
Time frame: Day 1
Pharmacokinetics (PK) of BEM/RZR Area under the plasma concentration-time curve (AUC)
Time frame: Day 1
Pharmacokinetics (PK) of BEM/RZR AUC
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bemnifosbuvir (BEM)/Ruzasvir (RZR) as a fixed-dose combination in people with Healthy Volunteer Study and Hepatic Impairment, run by Atea Pharmaceuticals, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK) of BEM/RZR Maximum plasma concentration (Cmax) (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.