Itraconazole for Drug Interaction Study
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of the study is to learn how itraconazole changes how the body processes the study medicine called PF-07248144. The study will also look at the safety, tolerability, and how PF-07248144 is changed and removed from the body after taking PF-07248144 alone compared to when it is taken with itraconazole.
Itraconazole can change how your body processes some medications so it may change the body's processing of PF-07248144. Multiple blood samples will be collected after each dose of PF-07248144 to determine how much PF-07248144 is in the blood at different times. This will help characterize the pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it) of PF-07248144 alone and when taken with itraconazole.
Who Is on the Research Team?
Pfizer CT.gov Call Center
Principal Investigator
Pfizer
Are You a Good Fit for This Trial?
This trial is for healthy adults who are not pregnant or breastfeeding, do not have childbearing potential, and agree to use contraception. Participants must be at least 18 years old with a BMI of 18-32 kg/m2 and weigh over 50 kg. They should not have used prescription drugs, supplements, or epigenetic agents recently and must avoid certain CYP2C9 or CYP3A4 inhibitors/inducers.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Period 1
Participants receive a single dose of PF-07248144, oral tablet on Day 1
Washout
A washout period of at least 14 days between Period 1 and Period 2
Period 2
Participants receive itraconazole oral solution once daily on Days 1-12 plus a single dose of PF-07248144, oral tablet on Day 4
Follow-up
Participants are monitored for safety and pharmacokinetics after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Itraconazole
- PF-07248144
Trial Overview
The study investigates how itraconazole affects the body's processing of PF-07248144. It examines the safety and tolerability of PF-07248144 alone versus combined with itraconazole by analyzing blood samples to track drug levels over time (pharmacokinetics).
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Period 1: PF-07248144 single dose, oral tablet on Day 1. Period 2: Itraconazole oral solution once daily on Days 1-12 plus PF-07248144 single dose, oral tablet on Day 4. Period 1 and Period 2 will be separated with a washout of at least 14 days
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
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