Drug-drug Interaction Study of Omeprazole and Bemnifosbuvir/Ruzasvir

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: Treatment E-Omeprazole 40 mg administered fasting; 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 F-Bemnifosbuvir/Ruzasvir FDC administered 2 hours after 40 mg dose Omeprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT07007806

AT-01B-011

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Arm (n=20)

Experimental group

Treatment:

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

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

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

Drug: Treatment B-Omeprazole 20 mg dose administered fasting

Drug: Treatment A-Bemnifosbuvir/Ruzasvir FDC administered fasting

Drug: Treatment E-Omeprazole 40 mg administered fasting