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

Phase 1CompletedNCT04784000

Atea Pharmaceuticals, Inc.20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Volunteer Study

Interventions

Period 1: AT-527 550 mgDRUG

AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1

Period 2: carbamazepineDRUG

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

Period 3: AT-527 550 mg + carbamazepineDRUG

AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Atea Study Site

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Pharmacokinetics (PK) of AT-527 (RO7496998)

Maximum plasma concentration (Cmax)

Time frame: Day 1 vs Day 26

Pharmacokinetics (PK) of AT-527 (RO7496998)

Area under the concentration-time curve (AUC)

Time frame: Day 1 vs Day 26

Data from ClinicalTrials.gov

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