NCT04784000

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Atea Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Healthy Volunteer Study

Interventions

Type	Name	Description
DRUG	Period 1: AT-527 550 mg	AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1
DRUG	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
DRUG	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
DRUG	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

Timeline

• Start date: 2021-03-01
• Primary completion: 2021-04-10
• Completion: 2021-04-10
• First posted: 2021-03-05
• Last updated: 2021-07-29

Locations

1 site across 1 country: Canada