Healthy Volunteer Study
Conditions
Brief summary
Drug-drug interaction study of Ruzasvir and Bemnifosbuvir
Interventions
DRUGCohort 1 BEM + Ruzasvir
Days 1 to 6 BEM under fasting conditions. Days 7 to 12 of BEM and Ruzasvir coadministered under fasting conditions. Days 13 to 18 of BEM and Ruzasvir coadministered under fed conditions
DRUGCohort 2 Ruzasvir + BEM
Days 1 to 6 of Ruzasvir under fasting conditions. Days 7 to 12 of Ruzasvir and BEM coadministered under fasting conditions. Days 13 to 18 of Ruzasvir and BEM coadministered under fed conditions
Sponsors
Atea Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug. * Minimum body weight of 50 kg and body mass index (BMI) of 18-29 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 |
|---|---|---|
| Pharmacokinetics (PK) of BEM | Days 6, 12, 18 | Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC) |
| Pharmacokinetics (PK) of Ruzasvir | Days 6, 12, 18 | Maximum plasma concentration (Cmax) and Area under the plasma concentration-time curve (AUC) |
Countries
Canada
Outcome results
None listed