Effect of Carbamazepine on the Pharmacokinetics (PK) of AT-527

Study Overview
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Brief Summary
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This study will determine the effect of carbamazepine on the PK of AT-527 (RO7496998) in healthy adult subjects.

Official Title
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A Phase 1 Study Assessing the Effect of Carbamazepine, a P-Glycoprotein Inducer, on the Pharmacokinetics of AT-527 in Healthy Adult Subjects

Conditions
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Healthy Volunteer Study

Intervention / Treatment
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* Drug: Period 1: AT-527 550 mg
* Drug: Period 2: carbamazepine
* Drug: Period 3: AT-527 550 mg + carbamazepine
* Drug: Period 3: AT-527 1100 mg + carbamazepine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AT-527 550 mg + carbamezepine<br> | Drug: Period 1: AT-527 550 mg<br>* AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1<br>* Other names: AT-527 is also known as RO7496998;Drug: Period 2: carbamazepine<br>* 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<br>Drug: Period 3: AT-527 550 mg + carbamazepine<br>* AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26<br>* Other names: AT-527 is also known as RO7496998;|
| Experimental: AT-527 1100 mg + carbamezepine<br> | Drug: Period 1: AT-527 550 mg<br>* AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1<br>* Other names: AT-527 is also known as RO7496998;Drug: Period 2: carbamazepine<br>* 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<br>Drug: Period 3: AT-527 1100 mg + carbamazepine<br>* AT-527 1100 mg tablet (2 x 550 mg tablets, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26<br>* Other names: AT-527 is also known as RO7496998;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) of AT-527 (RO7496998) | Maximum plasma concentration (Cmax) | Day 1 vs Day 26 | 
| Pharmacokinetics (PK) of AT-527 (RO7496998) | Area under the concentration-time curve (AUC) | Day 1 vs Day 26 |