Itraconazole for Drug Interaction Study
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand how itraconazole affects the body's processing of another drug, PF-07248144, an experimental treatment. Researchers seek to determine whether taking PF-07248144 alone or with itraconazole alters its absorption, breakdown, and elimination. Participants will take these medicines in different stages, with blood samples collected to monitor PF-07248144 levels. The trial seeks healthy men and women who cannot have children and have not recently used certain drugs or supplements. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
Yes, you will need to stop taking any prescription or nonprescription drugs, dietary, and herbal supplements at least 14 days before starting the study. You also cannot use certain foods or drugs that affect specific enzymes (CYP2C9 or CYP3A4) during the study and for 10 days after the last dose.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Researchers are studying the safety of PF-07248144 when used alone and with itraconazole. This study examines how itraconazole might affect the processing of PF-07248144 in the body. Previous research suggests that patients have tolerated PF-07248144 well.
Itraconazole, already FDA-approved for treating fungal infections, has had its interactions with other drugs studied before. The main goal of this study is to determine if itraconazole changes the amount of PF-07248144 in the blood.
As an early-stage study, the focus is on safety and tolerability. So far, no serious side effects have been reported, but this type of study is designed to closely monitor for any potential issues.12345Why are researchers excited about this trial's treatments?
Researchers are excited about the combination of PF-07248144 and itraconazole because it offers a new approach to understanding drug interactions that could enhance the effectiveness of existing treatments. Unlike standard antifungal or cancer treatments that are often used independently, this study explores how itraconazole can potentially influence the metabolism of PF-07248144, a novel compound. This interaction could lead to improved efficacy or safety profiles, opening the door for more personalized and effective therapy options in the future.
What evidence suggests that this trial's treatments could be effective?
This trial will evaluate the interaction between PF-07248144 and Itraconazole. Research has shown that PF-07248144 targets proteins that aid cancer cell growth, making it a promising treatment for some cancers. Participants will receive PF-07248144 both alone and with Itraconazole, which alters how the body processes medications and might enhance PF-07248144's effectiveness. Although no direct proof yet exists that these two drugs work well together, the study aims to determine their interaction. Early results suggest that PF-07248144 might be effective on its own, but more research is needed to confirm its effectiveness, especially when combined with Itraconazole.12567
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
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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
Citations
A Study to Learn if Itraconazole Changes How the Body ...
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.
Itraconazole for Drug Interaction Study · Info for Participants
The purpose of the study is to learn how itraconazole changes how the body processes the study medicine called PF-07248144.
Epigenetic Therapies in Endocrine-Related Cancers
The selective KAT6A/B inhibitor (KAT6i), PF-07248144, is currently undergoing a phase I study to evaluate its safety and efficacy, following PF- ...
2025 CPDD Abstract Booklet - 2025
The selection appeared to be based on the low risk of drug-drug interaction with study drugs and mechanism of drug-induced vomiting.
Drug-drug Interaction Study with AZD5305 and ...
This study is a single-arm, open-label, multi-centre drug-drug interaction (DDI) study of AZD5305 administered orally in patients with advanced solid ...
Pfizer Advances PF-07248144 With New Drug–Interaction ...
The trial compares PF-07248144 alone versus PF-07248144 taken together with itraconazole to see if itraconazole raises or lowers PF-07248144 ...
SPORANOX® (itraconazole) Capsules - accessdata.fda.gov
Drug Interactions: • Coadministration of a number of CYP3A4 substrates are contraindicated with. SPORANOX®. Some examples of drugs that are contraindicated ...
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