Healthy Volunteer Study
Conditions
Brief summary
Drug-drug interaction study of midazolam and AT-527 (R07496998)
Interventions
DRUGAT-527 550 mg + midazolam
Day 1: 2 mg midazolam Day 3: 550 mg AT-527 and 2 mg midazolam in the morning and a second 550 mg AT-527 dose in the evening. Days 4 to 6: 550 mg AT-527 administered twice daily (BID) Day 7: 550 mg AT-527 and 2 mg midazolam in the morning and a second 550 mg AT-527 dose in the evening. Other Names: AT-527 is also know as R07496998
Sponsors
Hoffmann-La Roche
Atea Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 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 * Females must have a negative pregnancy test at Screening and prior to dosing * 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 midazolam | Day 1, Day 3, Day 7 | Maximum plasma concentration (Cmax) and Area under the concentration-time curve (AUC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) of AT-527 | Day 3, Day 7 | Maximum plasma concentration (Cmax) and Area under the concentration-time curve (AUC) |
Countries
Canada
Outcome results
None listed