A Study to Learn if the Study Medicine Called Carbamazepine Changes How the Body Processes PF-07220060
NCT06897683 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14
Last updated 2025-11-25
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
- 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
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-03-21
- Primary Completion
- 2025-05-11
- Completion
- 2025-06-12
- FDA Drug
- Yes
Countries
- United States
Study Locations
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