Status:
COMPLETED
Effect of Carbamazepine on the Pharmacokinetics (PK) of AT-527
Lead Sponsor:
Atea Pharmaceuticals, Inc.
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Healthy Volunteer Study
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study will determine the effect of carbamazepine on the PK of AT-527 (RO7496998) in healthy adult subjects.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2021
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04784000
Start Date
March 1 2021
End Date
April 10 2021
Last Update
July 29 2021
Active Locations (1)
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1
Atea Study Site
Montreal, Quebec, Canada