NCT06897683

A Study to Learn if the Study Medicine Called Carbamazepine Changes How the Body Processes PF-07220060

A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSES OF CARBAMAZEPINE ON THE PHARMACOKINETICS OF SINGLE DOSE PF-07220060 ADMINISTERED UNDER THE FED CONDITION TO HEALTHY PARTICIPANTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to learn how carbamazepine changes how the body processes PF-07220060 in the body of healthy adults. This study will happen in 2 periods. The purpose of Period 1 of the study is to understand how the medicine is changed and eliminated from the body after it is taken) and safety of a single dose of PF-07220060. The purpose of Period 2 of the study is to understand how the medicine is changed and eliminated from the body after it is taken and safety of a single dose of PF-07220060 following multiple days dosing carbamazepine twice a day. Multiple blood samples will be collected in each period up to 120 hours after the PF-07220060 dose in order to measure the amount of PF-07220060 in the blood. On Day 1 in Period 1, a single oral dose of PF-07220060 will be administered with food. Period 2 will begin following the last blood sample collection in Period 1. Carbamazepine will be dosed in Period 2 at 100 mg twice a day on Days 1, 2, and 3, and then, will increase to 200 mg twice a day on Days 4, 5, 6, and 7, and will eventually increase to and be maintained at 300 mg twice a day for the rest of Period 2 from Day 8 to Day 18. On Day 14 in Period 2, a single oral dose of PF-07220060 will be administered.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	PF-07220060	Single dose PF-07220060 tablet administered with a moderate-fat standard calorie meal
DRUG	Carbamazepine ER Tablet	Carbamazepine dosing titration regimen in Period 2 from Day 1 to 18

Timeline

• Start date: 2025-03-21
• Primary completion: 2025-05-11
• Completion: 2025-06-12
• First posted: 2025-03-27
• Last updated: 2025-11-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study