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Completed

NCT Number: NCT07007806

Drug-drug Interaction Study of Omeprazole and Bemnifosbuvir/Ruzasvir

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

Completed

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Key information

Conditions

Healthy Volunteer Study

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Atea Study Site

Cypress, California, 90630, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Treatment A-Bemnifosbuvir/Ruzasvir FDC administered fasting

Drug

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.

Other names: BEM/RZR FDC, BEM (AT-527)/RZR (AT-038)

Treatment B-Omeprazole 20 mg dose administered fasting

Drug

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

Other names: Omeprazole, Prilosec®

Treatment C-Bemnifosbuvir/Ruzasvir FDC administered simultaneously with 20 mg dose of Omeprazole fasting

Drug

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).

Other names: BEM/RZR and Omeprazole, BEM (AT-527)/RZR (AT-038) and Prilosec®

Treatment D-Bemnifosbuvir/Ruzasvir FDC administered 0.5 hour prior to 20 mg dose of Omeprazole

Drug

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).

Other names: BEM/RZR and Omeprazole, BEM (AT-527)/RZR (AT-038) and Prilosec®

Treatment E-Omeprazole 40 mg administered fasting

Drug

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

Other names: Omeprazole, Prilosec®

Treatment F-Bemnifosbuvir/Ruzasvir FDC administered 2 hours after 40 mg dose Omeprazole

Drug

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).

Other names: BEM/RZR and Omeprazole, BEM (AT-527)/RZR (AT-038) and Prilosec®

Primary outcomes

  1. PK of BEM/RZR

    Time frame: Day 1, 8, 13, 18

    Cmax

  2. PK of BEM/RZR

    Time frame: Day 1, 7, 8, 13, 18

    AUC

  3. PK of Omeprazole

    Time frame: Day 7, 8

    Cmax

  4. PK of Omeprazole

    Time frame: Day 7, 8

    AUC

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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