Healthy Volunteer StudyPhase 1NCT07007806

Drug-drug Interaction Study of Omeprazole and Bemnifosbuvir/Ruzasvir

A Phase 1 study testing Treatment A-Bemnifosbuvir/Ruzasvir FDC administered fasting, Treatment B-Omeprazole 20 mg dose administered fasting and Treatment C-Bemnifosbuvir/Ruzasvir FDC administered simultaneously with 20 mg dose of Omeprazole fasting in people with Healthy Volunteer Study, run by Atea Pharmaceuticals, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Drug-drug interaction study between Omeprazole and Bemnifosbuvir/Ruzasvir (BEM/RZR) Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteer Study
What is being tested?: Treatment A-Bemnifosbuvir/Ruzasvir FDC administered fasting, Treatment B-Omeprazole 20 mg dose administered fasting and Treatment C-Bemnifosbuvir/Ruzasvir FDC administered simultaneously with 20 mg dose of Omeprazole fasting
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteUnited States
Study dates: 9 May 2025to 28 Jun 2025
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 55 years
All sexes
Healthy volunteers accepted
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 18.5-30 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 or SARS-CoV-2.
Abuse of alcohol or drugs.
Use of other investigational drugs within 28 days of dosing.
Concomitant use of prescription medications, or systemic over-the-counter medications.
Other clinically significant medical conditions or laboratory abnormalities.

Trial locations and contacts

1 site in 1 country.

United States1 site

Atea Study Site
Cypress, California, 90630

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Single-Sequence Study to Assess the Effect of Multiple Doses of Omeprazole on the Single-Dose Pharmacokinetics of Bemnifosbuvir/Ruzasvir Fixed-Dose Combination in Healthy Adult Participants

Drug-drug interaction study between Omeprazole and Bemnifosbuvir/Ruzasvir (BEM/RZR)

Conditions: Healthy Volunteer Study
Being tested: Treatment A-Bemnifosbuvir/Ruzasvir FDC administered fasting, Treatment B-Omeprazole 20 mg dose administered fasting, Treatment C-Bemnifosbuvir/Ruzasvir FDC administered simultaneously with 20 mg dose of Omeprazole fasting, Treatment D-Bemnifosbuvir/Ruzasvir FDC administered 0.5 hour prior to 20 mg dose of Omeprazole, Treatment E-Omeprazole 40 mg administered fasting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Treatment A-Bemnifosbuvir/Ruzasvir FDC administered fastingDrug
Also called BEM/RZR FDC, BEM (AT-527)/RZR (AT-038)
On day 1 single 550 mg/180 mg dose BEM/RZR FDC (2 × 275 mg/90 mg FDC tablets) will be administered under fasting conditions.
Treatment B-Omeprazole 20 mg dose administered fastingDrug
Also called Omeprazole, Prilosec®
On Day 4 to Day 13, a 20 mg dose omeprazole (1 × 20 mg) will be administered QD under fasting conditions.
Treatment C-Bemnifosbuvir/Ruzasvir FDC administered simultaneously with 20 mg dose of Omeprazole fastingDrug
Also called BEM/RZR and Omeprazole, BEM (AT-527)/RZR (AT-038) and Prilosec®
On Day 8, a single 550 mg/180 mg dose BEM/RZR FDC (2 × 275 mg/90 mg FDC tablets) will be administered under fasting conditions simultaneously with a 20 mg dose omeprazole (1 × 20 mg).
Treatment D-Bemnifosbuvir/Ruzasvir FDC administered 0.5 hour prior to 20 mg dose of OmeprazoleDrug
Also called BEM/RZR and Omeprazole, BEM (AT-527)/RZR (AT-038) and Prilosec®
On Day 13, a single 550 mg/180 mg dose BEM/RZR FDC (2 × 275 mg/90 mg FDC tablets) will be administered 0.5 hour before the administration of a 20 mg dose omeprazole (1 × 20 mg).
Treatment E-Omeprazole 40 mg administered fastingDrug
Also called Omeprazole, Prilosec®
On Day 14 to Day 22, a 40 mg dose omeprazole (2 × 20 mg) will be administered QD under fasting conditions.
Treatment F-Bemnifosbuvir/Ruzasvir FDC administered 2 hours after 40 mg dose OmeprazoleDrug
Also called BEM/RZR and Omeprazole, BEM (AT-527)/RZR (AT-038) and Prilosec®
On Day 18, a single 550 mg/180 mg dose BEM/RZR FDC (2 × 275 mg/90 mg FDC tablets) will be administered 2 hours after the administration of a 40 mg dose omeprazole (2 × 20 mg).

Study groups in NCT07007806
Study group	Role	What they receive
Arm (n=20)	Experimental	Not described Receives: Drug: Treatment A-Bemnifosbuvir/Ruzasvir FDC administered fasting; Drug: Treatment B-Omeprazole 20 mg dose administered fasting; Drug: Treatment C-Bemnifosbuvir/Ruzasvir FDC administered simultaneously with 20 mg dose of Omeprazole fasting; Drug: Treatment D-Bemnifosbuvir/Ruzasvir FDC administered 0.5 hour prior to 20 mg dose of Omeprazole; Drug: Treatment E-Omeprazole 40 mg administered fasting; Drug: Treatment F-Bemnifosbuvir/Ruzasvir FDC administered 2 hours after 40 mg dose Omeprazole

What is being measured

The primary outcome is the main question the study is designed to answer.

PK of BEM/RZR
Cmax
Measured: Day 1, 8, 13, 18
PK of BEM/RZR
AUC
Measured: Day 1, 7, 8, 13, 18
PK of Omeprazole
Cmax
Measured: Day 7, 8
PK of Omeprazole
AUC
Measured: Day 7, 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 May 202528 Jun 2025

First posted6 Jun 2025
Study start9 May 2025
Primary completion28 Jun 2025
Study completion28 Jun 2025

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: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07007806
Sponsor's protocol ID: AT-01B-011
Status last verified: Aug 2025
First submitted: 19 May 2025
Last updated: 29 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy Volunteer Study trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-Label, Single-Sequence Study to Assess the Effect of Multiple Doses of Omeprazole on the Single-Dose Pharmacokinetics of Bemnifosbuvir/Ruzasvir Fixed-Dose Combination in Healthy Adult Participants
ClinicalTrials.gov ID: NCT07007806
Acronym / sponsor ID: AT-01B-011
Conditions: Healthy Volunteer Study
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Atea Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 9 May 2025 (actual)
Primary completion: 28 Jun 2025 (actual)
Study completion: 28 Jun 2025 (actual)
First posted: 6 Jun 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.

Drug-drug interaction study between Omeprazole and Bemnifosbuvir/Ruzasvir (BEM/RZR)

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm (n=20)	Experimental	Drug: Treatment A-Bemnifosbuvir/Ruzasvir FDC administered fasting, Drug: Treatment B-Omeprazole 20 mg dose administered fasting, Drug: Treatment C-Bemnifosbuvir/Ruzasvir FDC administered simultaneously with 20 mg dose of Omeprazole fasting, Drug: Treatment D-Bemnifosbuvir/Ruzasvir FDC administered 0.5 hour prior to 20 mg dose of Omeprazole, Drug: Treatment E-Omeprazole 40 mg administered fasting, Drug: Treatment F-Bemnifosbuvir/Ruzasvir FDC administered 2 hours after 40 mg dose Omeprazole

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: 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 18.5-30 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 or SARS-CoV-2.
Abuse of alcohol or drugs.
Use of other investigational drugs within 28 days of dosing.
Concomitant use of prescription medications, or systemic over-the-counter medications.
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
Treatment A-Bemnifosbuvir/Ruzasvir FDC administered fastingAlso: BEM/RZR FDC, BEM (AT-527)/RZR (AT-038)On day 1 single 550 mg/180 mg dose BEM/RZR FDC (2 × 275 mg/90 mg FDC tablets) will be administered under fasting conditions.	Drug	Arm (n=20)
Treatment B-Omeprazole 20 mg dose administered fastingAlso: Omeprazole, Prilosec®On Day 4 to Day 13, a 20 mg dose omeprazole (1 × 20 mg) will be administered QD under fasting conditions.	Drug	Arm (n=20)
Treatment C-Bemnifosbuvir/Ruzasvir FDC administered simultaneously with 20 mg dose of Omeprazole fastingAlso: BEM/RZR and Omeprazole, BEM (AT-527)/RZR (AT-038) and Prilosec®On Day 8, a single 550 mg/180 mg dose BEM/RZR FDC (2 × 275 mg/90 mg FDC tablets) will be administered under fasting conditions simultaneously with a 20 mg dose omeprazole (1 × 20 mg).	Drug	Arm (n=20)
Treatment D-Bemnifosbuvir/Ruzasvir FDC administered 0.5 hour prior to 20 mg dose of OmeprazoleAlso: BEM/RZR and Omeprazole, BEM (AT-527)/RZR (AT-038) and Prilosec®On Day 13, a single 550 mg/180 mg dose BEM/RZR FDC (2 × 275 mg/90 mg FDC tablets) will be administered 0.5 hour before the administration of a 20 mg dose omeprazole (1 × 20 mg).	Drug	Arm (n=20)
Treatment E-Omeprazole 40 mg administered fastingAlso: Omeprazole, Prilosec®On Day 14 to Day 22, a 40 mg dose omeprazole (2 × 20 mg) will be administered QD under fasting conditions.	Drug	Arm (n=20)
Treatment F-Bemnifosbuvir/Ruzasvir FDC administered 2 hours after 40 mg dose OmeprazoleAlso: BEM/RZR and Omeprazole, BEM (AT-527)/RZR (AT-038) and Prilosec®On Day 18, a single 550 mg/180 mg dose BEM/RZR FDC (2 × 275 mg/90 mg FDC tablets) will be administered 2 hours after the administration of a 40 mg dose omeprazole (2 × 20 mg).	Drug	Arm (n=20)

Primary outcome

PK of BEM/RZR
Time frame: Day 1, 8, 13, 18
Cmax
PK of BEM/RZR
Time frame: Day 1, 7, 8, 13, 18
AUC
PK of Omeprazole
Time frame: Day 7, 8
Cmax
PK of Omeprazole
Time frame: Day 7, 8
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 29 Aug 2025.

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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.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

PK of BEM/RZR (time frame: Day 1, 8, 13, 18). 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?

On the ClinicalTrials.gov record for NCT07007806.

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 29 Aug 2025.