Healthy Volunteer Study
Conditions
Brief summary
Drug-drug interaction study between Omeprazole and Bemnifosbuvir/Ruzasvir (BEM/RZR)
Interventions
DRUGTreatment 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.
DRUGTreatment 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.
DRUGTreatment 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).
DRUGTreatment 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).
DRUGTreatment 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.
DRUGTreatment 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).
Sponsors
Atea Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK of BEM/RZR | Day 1, 8, 13, 18 | Cmax |
| PK of Omeprazole | Day 7, 8 | Cmax |
Countries
United States
Outcome results
None listed