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

Healthy Volunteer Study Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04784000
• Other study ID #: AT-03A-004
• Status: Completed
• Phase: Phase 1
• Start date: March 1, 2021
• Est. completion date: April 10, 2021

Study information

• Verified date: July 2021
• Source: Atea Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 10, 2021
• Est. primary completion date: April 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

Drug:
• Period 1: AT-527 550 mg
AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1
• Period 2: carbamazepine
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 + carbamazepine
AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26
• Period 3: AT-527 1100 mg + carbamazepine
AT-527 1100 mg tablet (2 x 550 mg tablets, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26

Locations

Country	Name	City	State
Canada	Atea Study Site	Montreal	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Atea Pharmaceuticals, Inc.	Hoffmann-La Roche

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK) of AT-527 (RO7496998)	Maximum plasma concentration (Cmax)	Day 1 vs Day 26
Primary	Pharmacokinetics (PK) of AT-527 (RO7496998)	Area under the concentration-time curve (AUC)	Day 1 vs Day 26