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

NCT06897683 | Completed Phase 1 FDA Drug

• 1 other identifier: C4391012
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Adults

Keywords

PF-07220060; Carbamazepine; Drug-drug interaction

Outcome Measures

Primary Outcomes (2)

• Plasma PF-07220060 Maximum Observed Plasma Concentration (Cmax)

  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.

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

  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 (4)

• Number of Participants With Laboratory Abnormalities

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

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

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

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

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

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

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

Study Arms (2)

Period 1

EXPERIMENTAL

Single dose PF-07220060 alone

Drug: PF-07220060

Period 2

EXPERIMENTAL

Single dose PF-07220060 given after multiple doses of carbamazepine

Drug: PF-07220060; Drug: Carbamazepine ER Tablet

Interventions

PF-07220060 DRUG

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

Period 1; Period 2

Carbamazepine ER Tablet DRUG

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

Period 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an open-label, fixed sequence, two-period, crossover study in healthy participants.

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: March 27, 2025
• Study Start: March 21, 2025
• Primary Completion: May 11, 2025
• Study Completion: June 12, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)