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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy Adults

Treatments: Drug: PF-07220060; Drug: Carbamazepine ER Tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06897683

C4391012

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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.

Key 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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Period 1

Experimental group

Description:

Single dose PF-07220060 alone

Treatment:

Drug: PF-07220060

Period 2

Experimental group

Description:

Single dose PF-07220060 given after multiple doses of carbamazepine

Treatment:

Drug: Carbamazepine ER Tablet

Drug: PF-07220060