Healthy Volunteer StudyPhase 1NCT07314346
Drug-drug Interaction Study of Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
A Phase 1 study testing Buprenorphine/Naloxone + BEM/RZR and Methadone +BEM/RZR in people with Healthy Volunteer Study, run by Atea Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- Buprenorphine/Naloxone + BEM/RZR and Methadone +BEM/RZR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Jan 2025to 23 Jul 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must agree to use acceptable contraceptive methods through at least 90 days after the last dose of study drug.
- Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/ m2.
- Willing to comply with the study requirements and to provide written informed consent.
Who cannot join
- Infected with hepatitis B virus, hepatitis C virus, HIV.
- Abuse of alcohol or drugs.
- Use of other investigational drugs within 28 days prior to Day -5.
- Concomitant use of prescription medications, or systemic over-the-counter medications (apart from methadone or buprenorphine/naloxone as assigned maintenance therapy).
- Other clinically significant medical conditions or laboratory abnormalities.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Atea Study Site
Hollywood, Florida, 33019
Atea Study Site
Marlton, New Jersey, 08053
Atea Study Site
Overland Park, Kansas, 66212
About this study
Official title: A Phase 1, Open-Label, Two-Part, Single-Sequence Study to Evaluate the Effect of Multiple Oral Doses of BEM/RZR FDC on the Pharmacokinetics of Buprenorphine/Naloxone or Methadone in Participants on Stable Maintenance Therapy for Opiate Withdrawal
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
- Conditions
- Healthy Volunteer Study
- Being tested
- Buprenorphine/Naloxone + BEM/RZR, Methadone +BEM/RZR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Buprenorphine/Naloxone + BEM/RZRDrug
Also called BEM (AT-527)/RZR (AT-038)
Day -5 to Day -1:buprenorphine/naloxone as individualized QD doses up to 24mg/6mg.
Day 1 to Day 5:Individualized QD doses of buprenorphine/naloxone. Day 6 to Day 12:Individualized QD doses of buprenorphine/naloxone + BEM 550mg/RZR 180mg QD.
Day 13 Individualized QD doses of buprenorphine/naloxone.
Methadone +BEM/RZRDrug
Also called BEM (AT-527)/RZR (AT-038)
Day -5 to Day -1:methadone individualized QD doses: 30-150mg. Day 1 to Day 5:Individualized QD does of methadone. Day 6 to Day 12:Individualized QD doses of methadone + BEM 550mg/RZR 180mg QD. Day 13 Individualized QD doses of methadone.
| Study group | Role | What they receive |
|---|---|---|
| (n=16) buprenorphine/naloxone + BEM/RZR | Experimental | Not described Receives: Drug: Buprenorphine/Naloxone + BEM/RZR |
| (n=16) methadone + BEM/RZR | Experimental | Not described Receives: Drug: Methadone +BEM/RZR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone
Cmax
Measured: Day -5 to Day 13
Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone
AUC
Measured: Day -5 to Day 13
Effect of BEM/RZR on PK of methadone
Cmax
Measured: Day -5 to Day 13
Effect of BEM/RZR on PK of methadone
AUC
Measured: Day -5 to Day 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start7 Jan 2025
- Primary completion23 Jul 2026
- Study completion23 Jul 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT07314346
- Sponsor's protocol ID
- AT-01B-013
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 28 Oct 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Two-Part, Single-Sequence Study to Evaluate the Effect of Multiple Oral Doses of BEM/RZR FDC on the Pharmacokinetics of Buprenorphine/Naloxone or Methadone in Participants on Stable Maintenance Therapy for Opiate Withdrawal
- ClinicalTrials.gov ID
- NCT07314346
- Acronym / sponsor ID
- AT-01B-013
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 23 Jul 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 2 Jan 2026 (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.
Drug-drug interaction study between Bemnifosbuvir/Ruzasvir (BEM/RZR) and Buprenorphine/Naloxone or Methadone
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (n=16) buprenorphine/naloxone + BEM/RZR | Experimental | Drug: Buprenorphine/Naloxone + BEM/RZR |
| (n=16) methadone + BEM/RZR | Experimental | Drug: Methadone +BEM/RZR |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must agree to use acceptable contraceptive methods through at least 90 days after the last dose of study drug.
- Minimum body weight of 50 kg and body mass index (BMI) of 18-32 kg/ m2.
- Willing to comply with the study requirements and to provide written informed consent.
Key exclusion criteria (5 listed)
- Infected with hepatitis B virus, hepatitis C virus, HIV.
- Abuse of alcohol or drugs.
- Use of other investigational drugs within 28 days prior to Day -5.
- Concomitant use of prescription medications, or systemic over-the-counter medications (apart from methadone or buprenorphine/naloxone as assigned maintenance therapy).
- 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 |
|---|---|---|
| Buprenorphine/Naloxone + BEM/RZRAlso: BEM (AT-527)/RZR (AT-038)Day -5 to Day -1:buprenorphine/naloxone as individualized QD doses up to 24mg/6mg. Day 1 to Day 5:Individualized QD doses of buprenorphine/naloxone. Day 6 to Day 12:Individualized QD doses of buprenorphine/naloxone + BEM 550mg/RZR 180mg QD. Day 13 Individualized QD doses of buprenorphine/naloxone. | Drug | (n=16) buprenorphine/naloxone + BEM/RZR |
| Methadone +BEM/RZRAlso: BEM (AT-527)/RZR (AT-038)Day -5 to Day -1:methadone individualized QD doses: 30-150mg. Day 1 to Day 5:Individualized QD does of methadone. Day 6 to Day 12:Individualized QD doses of methadone + BEM 550mg/RZR 180mg QD. Day 13 Individualized QD doses of methadone. | Drug | (n=16) methadone + BEM/RZR |
Primary outcome
Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone
Time frame: Day -5 to Day 13
Cmax
Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone
Time frame: Day -5 to Day 13
AUC
Effect of BEM/RZR on PK of methadone
Time frame: Day -5 to Day 13
Cmax
Effect of BEM/RZR on PK of methadone
Time frame: Day -5 to Day 13
AUC
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 28 Oct 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.
3 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 Buprenorphine/Naloxone + BEM/RZR and Methadone +BEM/RZR in people with Healthy Volunteer Study, run by Atea Pharmaceuticals, Inc. at 3 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 3 inclusion and 5 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 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Effect of BEM/RZR on PK of buprenorphine,norbuprenorphine and naloxone (time frame: Day -5 to Day 13). The study lists 4 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 28 Oct 2026.