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

Launched by PFIZER · Mar 20, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to investigate how a medication called carbamazepine affects the way the body processes another medicine known as PF-07220060 in healthy adults. The study involves two main periods. In the first period, participants will take a single dose of PF-07220060, and researchers will monitor how the body changes and eliminates this medication over time. During the second period, participants will take carbamazepine twice a day for several days before receiving another dose of PF-07220060, allowing scientists to see how the combination of these medicines works in the body.

To participate in this study, you need to be a healthy adult between the ages of 18 and 65, with a specific body weight and health status. It’s important that you have no history of certain medical conditions or sensitivities to the medications involved. Participants will need to provide blood samples during the study to help measure how the medications are processed in their bodies. This trial is not yet recruiting, but if you’re eligible and choose to participate, you can expect to help researchers learn more about how these medications interact, which could help improve treatment options in the future.

Gender

ALL

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.