NCT07007806

Drug-drug Interaction Study of Omeprazole and Bemnifosbuvir/Ruzasvir

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Atea Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	Treatment A-Bemnifosbuvir/Ruzasvir FDC administered fasting	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	Treatment B-Omeprazole 20 mg dose administered fasting	On Day 4 to Day 13, a 20 mg dose omeprazole (1 × 20 mg) will be administered QD under fasting conditions.
DRUG	Treatment C-Bemnifosbuvir/Ruzasvir FDC administered simultaneously with 20 mg dose of Omeprazole fasting	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	Treatment D-Bemnifosbuvir/Ruzasvir FDC administered 0.5 hour prior to 20 mg dose of Omeprazole	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	Treatment E-Omeprazole 40 mg administered fasting	On Day 14 to Day 22, a 40 mg dose omeprazole (2 × 20 mg) will be administered QD under fasting conditions.
DRUG	Treatment F-Bemnifosbuvir/Ruzasvir FDC administered 2 hours after 40 mg dose Omeprazole	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).

Timeline

• Start date: 2025-05-09
• Primary completion: 2025-06-28
• Completion: 2025-06-28
• First posted: 2025-06-06
• Last updated: 2025-08-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study