Healthy Volunteer Study
Conditions
Brief summary
This study will determine the effect of carbamazepine on the PK of AT-527 (RO7496998) in healthy adult subjects.
Interventions
DRUGPeriod 1: AT-527 550 mg
AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1
DRUGPeriod 2: carbamazepine
Carbamazepine 100 mg twice daily (BID) Days 3 to 6, 200 mg BID on Days 9 to 11, 300 mg BID on Days 12 to 25
DRUGPeriod 3: AT-527 550 mg + carbamazepine
AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26
DRUGPeriod 3: AT-527 1100 mg + carbamazepine
AT-527 1100 mg tablet (2 x 550 mg tablets, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26
Sponsors
Hoffmann-La Roche
Atea Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
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
* Pregnant or breastfeeding * Infected with hepatitis B virus, hepatitis C virus, HIV or COVID-19 * Abuse of alcohol or drugs * Use of other investigational drugs within 28 days of dosing * Use of other prescription drugs with 28 days of dosing * Other clinically significant medical conditions or laboratory abnormalities
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK) of AT-527 (RO7496998) | Day 1 vs Day 26 | Maximum plasma concentration (Cmax) |
Countries
Canada
Outcome results
None listed