NCT07007806

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started May 2025

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

June 6, 2025

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2025

Completed
Last Updated

August 29, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

May 19, 2025

Last Update Submit

August 25, 2025

Conditions

Healthy Volunteer Study

Outcome Measures

Primary Outcomes (4)

  • PK of BEM/RZR

    Cmax

    Day 1, 8, 13, 18

  • PK of BEM/RZR

    AUC

    Day 1, 7, 8, 13, 18

  • PK of Omeprazole

    Cmax

    Day 7, 8

  • PK of Omeprazole

    AUC

    Day 7, 8

Study Arms (1)

Arm (n=20)

EXPERIMENTAL
Drug: Treatment A-Bemnifosbuvir/Ruzasvir FDC administered fastingDrug: Treatment B-Omeprazole 20 mg dose administered fastingDrug: Treatment C-Bemnifosbuvir/Ruzasvir FDC administered simultaneously with 20 mg dose of Omeprazole fastingDrug: Treatment D-Bemnifosbuvir/Ruzasvir FDC administered 0.5 hour prior to 20 mg dose of OmeprazoleDrug: Treatment E-Omeprazole 40 mg administered fastingDrug: Treatment F-Bemnifosbuvir/Ruzasvir FDC administered 2 hours after 40 mg dose Omeprazole

Interventions

Treatment A-Bemnifosbuvir/Ruzasvir FDC administered fastingDRUG

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.

Also known as: BEM/RZR FDC, BEM (AT-527)/RZR (AT-038)
Arm (n=20)
Treatment B-Omeprazole 20 mg dose administered fastingDRUG

On Day 4 to Day 13, a 20 mg dose omeprazole (1 × 20 mg) will be administered QD under fasting conditions.

Also known as: Omeprazole, Prilosec®
Arm (n=20)
Treatment C-Bemnifosbuvir/Ruzasvir FDC administered simultaneously with 20 mg dose of Omeprazole fastingDRUG

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).

Also known as: BEM/RZR and Omeprazole, BEM (AT-527)/RZR (AT-038) and Prilosec®
Arm (n=20)
Treatment D-Bemnifosbuvir/Ruzasvir FDC administered 0.5 hour prior to 20 mg dose of OmeprazoleDRUG

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).

Also known as: BEM/RZR and Omeprazole, BEM (AT-527)/RZR (AT-038) and Prilosec®
Arm (n=20)
Treatment E-Omeprazole 40 mg administered fastingDRUG

On Day 14 to Day 22, a 40 mg dose omeprazole (2 × 20 mg) will be administered QD under fasting conditions.

Also known as: Omeprazole, Prilosec®
Arm (n=20)
Treatment F-Bemnifosbuvir/Ruzasvir FDC administered 2 hours after 40 mg dose OmeprazoleDRUG

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).

Also known as: BEM/RZR and Omeprazole, BEM (AT-527)/RZR (AT-038) and Prilosec®
Arm (n=20)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atea Study Site

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

OmeprazoleLead

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingMetals, HeavyElementsInorganic ChemicalsMetals

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2025

First Posted

June 6, 2025

Study Start

May 9, 2025

Primary Completion

June 28, 2025

Study Completion

June 28, 2025

Last Updated

August 29, 2025

Record last verified: 2025-08

Locations

US(1)