Status:
COMPLETED
A Study to Learn if the Study Medicine Called Carbamazepine Changes How the Body Processes PF-07220060
Lead Sponsor:
Pfizer
Conditions:
Healthy Adults
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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 s...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
March 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2025
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06897683
Start Date
March 21 2025
End Date
June 12 2025
Last Update
November 25 2025
Active Locations (1)
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1
Pfizer Clinical Research Unit - New Haven
New Haven, Connecticut, United States, 06511