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Completed

NCT Number: NCT07198035

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

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.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-07248144

Drug

Participants will receive a single dose of PF-07248144 by mouth in Period 1 on Day 1 and Period 2 on Day 14, with a washout period of at least 14 days between two doses of PF-07248144

carbamazepine

Drug

Participants will receive Carbamazepine by mouth 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.

Other names: Tegretol

Primary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) Period 1

    Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose

  2. Cmax Period 2

    Time frame: Day 14: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose

  3. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) Period 1

    Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose

  4. AUCinf Period 2

    Time frame: Day 14: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose

  5. Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast). Period 1. To be used as the primary endpoint if AUCinf cannot be reliably estimated

    Time frame: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose

  6. AUClast. Period 2. To be used as the primary endpoint if AUCinf cannot be reliably estimated

    Time frame: Day 14: 0 (pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120 and 168 hours post-dose

Secondary outcomes

  1. Number of Treatment-Emergent Treatment-Related AEs by Severity

    Time frame: From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days)

  2. Number of Participants With Laboratory Test Abnormalities

    Time frame: From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days)

  3. Number of Participants With Clinically Significant Physical Examination Abnormalities

    Time frame: From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days)

  4. Number of Participants With Vital Signs Values Meeting Categorical Summarization Criteria

    Time frame: From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days)

  5. Number of Participants With Clinically Significant Changes From Baseline in 12-Lead Electrocardiogram (ECG) Parameters

    Time frame: From Day 1 of dosing up to 35 days after last of study intervention (maximum up to 55 days)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF CARBAMAZEPINE ON PF-07248144 PHARMACOKINETICS

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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