Drug-drug Interaction Study of Omeprazole and Bemnifosbuvir/Ruzasvir

Phase 1

Completed

• Conditions: Healthy Volunteer Study
• Interventions: 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

• Registration Number: NCT07007806
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-09
• Study First Submitted: 2025-05-19
• Study First Submitted QC: 2025-05-28
• Study First Posted: 2025-06-06
• Primary Completion: 2025-06-28
• Study Completion: 2025-06-28
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-25
• Last Update Posted: 2025-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Arm (n=20)	Treatment A-Bemnifosbuvir/Ruzasvir FDC administered fasting	-
Arm (n=20)	Treatment B-Omeprazole 20 mg dose administered fasting	-
Arm (n=20)	Treatment C-Bemnifosbuvir/Ruzasvir FDC administered simultaneously with 20 mg dose of Omeprazole fasting	-
Arm (n=20)	Treatment D-Bemnifosbuvir/Ruzasvir FDC administered 0.5 hour prior to 20 mg dose of Omeprazole	-
Arm (n=20)	Treatment E-Omeprazole 40 mg administered fasting	-
Arm (n=20)	Treatment F-Bemnifosbuvir/Ruzasvir FDC administered 2 hours after 40 mg dose Omeprazole	-

Primary Outcome Measures

Name	Time	Method
PK of BEM/RZR	Day 1, 7, 8, 13, 18	AUC
PK of Omeprazole	Day 7, 8	AUC

Trial Locations

Locations (1)

Atea Study Site; 🇺🇸 Cypress, California, United States