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

Phase 1

Not yet recruiting

• Conditions: Healthy Adults
• Interventions: Drug: PF-07220060; Drug: Carbamazepine ER Tablet

• Registration Number: NCT06897683
• Lead Sponsor: Pfizer

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-20
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study Start: 2025-03-21
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-07-14
• Study Completion: 2025-07-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Period 1	PF-07220060	Single dose PF-07220060 alone
Period 2	PF-07220060	Single dose PF-07220060 given after multiple doses of carbamazepine
Period 2	Carbamazepine ER Tablet	Single dose PF-07220060 given after multiple doses of carbamazepine

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Clinical Research Unit - New Haven; 🇺🇸 New Haven, Connecticut, United States