A Study to Learn if Multiple Doses of the Study Medicine Called Carbamazepine Changes How the Body Processes the Other Study Medicine PF-07248144

Pfizer

Status and phase: Enrolling; Phase 1

Conditions: Healthy Adults

Treatments: Drug: PF-07248144; Drug: Carbamazepine

Study type: Interventional

Funder types: Industry

Identifiers

NCT07198035

C4551007

2025-522331-34-00 (Registry Identifier)

Details and patient eligibility

About

The purpose of the study is to learn how the study medicine called carbamazepine changes how the body processes the other study medicine called PF-07248144. The study will also look at the safety, tolerability, and how PF-07248144 is changed and removed from the body after taking PF-07248144 alone compared to when it is taken with carbamazepine.

Carbamazepine can change how your body processes some medications so it may change the body's processing of PF-07248144. Multiple blood samples will be collected up to 8 days after each dose of PF-07248144 to determine how much PF-07248144 is in the blood at different times. This will help characterize the pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it) of PF-07248144 alone and when taken with carbamazepine.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

• Females of nonchildbearing potential and males, inclusive, at screening who are able to provide consent and are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead electrocardiogram (ECG)s.
• Body mass index (BMI) of 16-32 kg/m2; and a total body weight >45 kg (99 lb).

Exclusion

• Participants shown to carry or be positive for human leukocyte antigen (HLA)-B*1502 and/or HLA-A*3101 (genotyping alleles/markers related with carbamazepine-associated Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis [TEN]).
• Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
• Additionally, current use or anticipated need for food or drugs that are known moderate or strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days or 5 half-lives of the strong inducers or inhibitors of CYP2C9 or CYP3A4, whichever is longer, prior to first dose of study intervention, during the treatment period, and within 10 days after the last dose of PF-07248144.
• Pregnant female participants; breastfeeding female participants; individual(s) of childbearing potential (IOCBPs); fertile male participants who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 103 days after the last dose of study intervention.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 1 patient group

PF-07248144 with and without Carbamazepine

Experimental group

Description:

PF-07248144 administered as a single dose in Period 1 on Day 1 and in Period 2 on Day 14. Carbamazepine administered once a day for Day 1 through 3, then twice a day for Day 4 through 7, and then three times daily for Day 8 through 20 in Period 2

Treatment:

Drug: Carbamazepine

Drug: PF-07248144