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CompletedNCT06897683Updated Nov 25, 2025

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

A Phase 1 interventional study of PF-07220060 and Carbamazepine ER Tablet in Healthy Adults, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Pfizer · Phase 1, Interventional, and Basic science

From the registry’s dates

  • Primary completion was May 2025, 1 year 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Adults

Keywords

  • PF-07220060
  • Carbamazepine
  • Drug-drug interaction
03

In context

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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.
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Period 1

    Single dose PF-07220060 alone

    Drug: PF-07220060

  • Experimental
    Period 2

    Single dose PF-07220060 given after multiple doses of carbamazepine

    Drug: PF-07220060 · Drug: Carbamazepine ER Tablet

Interventions

  • DrugPF-07220060

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

  • DrugCarbamazepine ER Tablet

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

06

What researchers measure

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

07

Study locations

1 site
  • Pfizer Clinical Research Unit - New Haven
    New Haven, Connecticut 06511, United States
08

References and documents

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06897683
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Mar 27, 2025
Start date
Mar 21, 2025
Primary completion
May 11, 2025
Completion
Jun 12, 2025
Last update
Nov 25, 2025

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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