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Completed

NCT Number: NCT06897683

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

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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Key information

Conditions

Healthy Adults

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

PF-07220060

Drug

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

Carbamazepine ER Tablet

Drug

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

Primary outcomes

  1. Plasma PF-07220060 Maximum Observed Plasma Concentration (Cmax)

    Time frame: Pre-dose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose.

  2. Plasma PF-07220060 Area under the plasma concentration versus time curve (AUC)

    Time frame: Pre-dose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 72, 96 and 120 hours post-dose.

Secondary outcomes

  1. Number of Participants With Laboratory Abnormalities

    Time frame: From baseline up to 28 to 35 days after last dose of investigational drug

  2. Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings

    Time frame: From baseline up to 28 to 35 days after last dose of investigational drug

  3. Number of Participants With Clinically Significant Change From Baseline in Vital Signs

    Time frame: From baseline up to 28 to 35 days after last dose of investigational drug

  4. Number of Participants With Treatment-Emergent Adverse Events (AEs)

    Time frame: From baseline up to 28 to 35 days after last dose of investigational drug

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD STUDY TO ESTIMATE THE EFFECT OF MULTIPLE DOSES OF CARBAMAZEPINE ON THE PHARMACOKINETICS OF SINGLE DOSE PF-07220060 ADMINISTERED UNDER THE FED CONDITION TO HEALTHY PARTICIPANTS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 27, 2025
Registry last updated
Nov 25, 2025

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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