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

Phase 1

Completed

• Conditions: Healthy Volunteer Study

• Registration Number: NCT04784000
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-01
• Study First Submitted: 2021-03-03
• Study First Submitted QC: 2021-03-03
• Study First Posted: 2021-03-05
• Primary Completion: 2021-04-10
• Study Completion: 2021-04-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK) of AT-527 (RO7496998)	Day 1 vs Day 26	Area under the concentration-time curve (AUC)

Trial Locations

Locations (1)

Atea Study Site; 🇨🇦 Montreal, Quebec, Canada