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

Atea Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteer Study

Treatments: Drug: Period 2: carbamazepine; Drug: Period 3: AT-527 550 mg + carbamazepine; Drug: Period 3: AT-527 1100 mg + carbamazepine; Drug: Period 1: AT-527 550 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT04784000

AT-03A-004

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

AT-527 550 mg + carbamezepine

Experimental group

Treatment:

Drug: Period 1: AT-527 550 mg

Drug: Period 3: AT-527 550 mg + carbamazepine

Drug: Period 2: carbamazepine

AT-527 1100 mg + carbamezepine

Experimental group

Treatment:

Drug: Period 1: AT-527 550 mg

Drug: Period 3: AT-527 1100 mg + carbamazepine

Drug: Period 2: carbamazepine