Clinical trial NCT06897683: A Study to Learn if the Study Medicine Called Carbamazepine Changes How the Body Processes PF-07220060
Official 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Healthy Adults
Keywords: PF-07220060
Carbamazepine
Drug-drug interaction
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2025-03-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is an open-label, fixed sequence, two-period, crossover study in healthy participants.
Primary purpose: BASIC_SCIENCE

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.


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.

Primary outcomes:
measure: Plasma PF-07220060 Maximum Observed Plasma Concentration (Cmax)
timeFrame: 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.
measure: Plasma PF-07220060 Area under the plasma concentration versus time curve (AUC)
timeFrame: 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:
measure: Number of Participants With Laboratory Abnormalities
timeFrame: From baseline up to 28 to 35 days after last dose of investigational drug
measure: Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings
timeFrame: From baseline up to 28 to 35 days after last dose of investigational drug
measure: Number of Participants With Clinically Significant Change From Baseline in Vital Signs
timeFrame: From baseline up to 28 to 35 days after last dose of investigational drug
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs)
timeFrame: From baseline up to 28 to 35 days after last dose of investigational drug
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Clinical Research Unit - New Haven
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: