Status:
RECRUITING
A Study to Learn if Multiple Doses of the Study Medicine Called Carbamazepine Changes How the Body Processes the Other Study Medicine PF-07248144
Lead Sponsor:
Pfizer
Conditions:
Healthy Adults
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of the study is to learn how the study medicine called carbamazepine changes how the body processes the other study medicine called PF-07248144. The study will also look at the safety, tol...
Eligibility Criteria
Inclusion
- Inclusion
- Females of nonchildbearing potential and males, inclusive, at screening who are able to provide consent and are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead electrocardiogram (ECG)s.
- Body mass index (BMI) of 16-32 kg/m2; and a total body weight \>45 kg (99 lb).
- Exclusion
- Participants shown to carry or be positive for human leukocyte antigen (HLA)-B\*1502 and/or HLA-A\*3101 (genotyping alleles/markers related with carbamazepine-associated Stevens-Johnson syndrome (SJS) or toxic epidermal necrolysis \[TEN\]).
- Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
- Additionally, current use or anticipated need for food or drugs that are known moderate or strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days or 5 half-lives of the strong inducers or inhibitors of CYP2C9 or CYP3A4, whichever is longer, prior to first dose of study intervention, during the treatment period, and within 10 days after the last dose of PF-07248144.
- Pregnant female participants; breastfeeding female participants; individual(s) of childbearing potential (IOCBPs); fertile male participants who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 103 days after the last dose of study intervention.
Exclusion
Key Trial Info
Start Date :
September 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 26 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07198035
Start Date
September 18 2025
End Date
December 26 2025
Last Update
September 30 2025
Active Locations (1)
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1
Pfizer Clinical Research Unit - Brussels
Brussels, Other, Belgium, B-1070