Carbamazepine for Drug Interaction Study in Healthy Adults
Trial Summary
Do I have to stop taking my current medications for the trial?
Yes, you will need to stop taking any prescription or nonprescription drugs, dietary, and herbal supplements at least 7 days or 5 half-lives before the trial starts. Also, you cannot use medications that strongly affect certain liver enzymes up to 56 days before the trial.
What data supports the effectiveness of the drug Carbamazepine?
Is carbamazepine generally safe for humans?
How does the drug carbamazepine differ from other treatments?
Carbamazepine is unique because it not only treats epilepsy and certain types of pain but also has a complex interaction profile with other drugs due to its ability to induce and be affected by liver enzymes that metabolize many medications. This means it can change how other drugs work in the body, which is different from many other treatments that do not have such extensive drug interaction potential.12489
What is the purpose of this trial?
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.
Research Team
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Eligibility Criteria
This trial is for healthy adults who want to help understand how the body processes a medicine called PF-07220060, both alone and when taken with another drug called Carbamazepine. Specific eligibility details are not provided, but typically participants must meet certain health standards.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Period 1
Single dose of PF-07220060 administered with food to understand pharmacokinetics and safety
Period 2
Single dose of PF-07220060 administered after multiple doses of carbamazepine to understand pharmacokinetics and safety
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Carbamazepine
- PF-07220060
Find a Clinic Near You
Who Is Running the Clinical Trial?
Pfizer
Lead Sponsor
Albert Bourla
Pfizer
Chief Executive Officer since 2019
PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki
Patrizia Cavazzoni
Pfizer
Chief Medical Officer
MD from McGill University