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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-21

Study Completion Date

2025-06-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Adults

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

This is an open-label, fixed sequence, two-period, crossover study in healthy participants.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Open label

Study Groups

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Period 1

Single dose PF-07220060 alone

Group Type EXPERIMENTAL

PF-07220060

Intervention Type DRUG

Single dose PF-07220060 tablet administered with a moderate-fat standard calorie meal

Period 2

Single dose PF-07220060 given after multiple doses of carbamazepine

Group Type EXPERIMENTAL

PF-07220060

Intervention Type DRUG

Single dose PF-07220060 tablet administered with a moderate-fat standard calorie meal

Carbamazepine ER Tablet

Intervention Type DRUG

Carbamazepine dosing titration regimen in Period 2 from Day 1 to 18

Interventions

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PF-07220060

Single dose PF-07220060 tablet administered with a moderate-fat standard calorie meal

Intervention Type DRUG

Carbamazepine ER Tablet

Carbamazepine dosing titration regimen in Period 2 from Day 1 to 18

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female participants aged 18 to 65 years at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
* Body mass index (BMI) of 17.5-30.5 kg/m2; and a total body weight \>50 kg (110 lb).
* Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.
* Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

Exclusion Criteria

* Participants shown to carry or be positive for human leukocyte antigen (HLA)-B\*1502 and HLA-A\*3101 (genotyping alleles/markers related with carbamazepine-associated SJS or TEN).
* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
* Concomitant use of any medications or substances that are strong inducers or inhibitors of CYP3A4 or UGT2B7 are prohibited within 5 half-lives plus 14 days (up to 56 days) prior to first dose of PF 07220060.
* Previous administration with a study intervention (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer).
* History of sensitivity to carbamazepine, tricyclic compounds, or any of the formulation components of carbamazepine.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes