Itraconazole for Drug Interaction Study

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Pfizer

Disqualifiers: Significant disease, Abnormal safety assessments

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if itraconazole, an antifungal medication, affects how the body processes PF-08642534, an experimental treatment. Participants will take PF-08642534 alone and with itraconazole to observe any changes. The trial seeks healthy adults with a BMI between 16 and 30, weighing more than 50 kilograms (about 110 pounds). Participants will stay at the clinic for about four weeks, with additional time for screening and follow-up. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that you may need to pause certain medications. Please check with the study team for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that PF-08642534 is generally well-tolerated, meaning most people can take it without problems. It has proven safe in other uses, suggesting it is likely safe for participants in this trial. Itraconazole, the other medicine in this study, already has approval for treating fungal infections. Known to interact with many other drugs, this study aims to understand its interactions better. While itraconazole itself is considered safe, the researchers are closely studying its interaction with PF-08642534 to ensure safety. Participants will receive careful monitoring for any unexpected interactions or side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about PF-08642534 because it offers a novel approach to drug interactions when paired with itraconazole. Unlike traditional treatments that primarily focus on independent drug efficacy, this combination is being explored to understand how itraconazole might affect the absorption and effectiveness of PF-08642534. This could lead to more personalized medicine options, tailoring treatments based on how drugs interact in the body, potentially increasing effectiveness and safety for patients.

What evidence suggests that this trial's treatments could be effective?

Research has shown that itraconazole can alter how the body processes certain medicines by affecting the enzymes responsible for their breakdown. This trial will compare two treatment arms: one where participants receive a single dose of PF-08642534, and another where participants receive PF-08642534 alongside itraconazole. The main goal is to understand how itraconazole affects PF-08642534, a new experimental medicine. Although specific information on PF-08642534's effectiveness for treating conditions is not yet available, itraconazole is already known to effectively treat fungal infections. In this study, itraconazole is used to determine if it changes how long PF-08642534 remains in the body or affects its safety. ^{1 6 7 8 9}

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 aged 18 to 65 with a BMI between 16 and 30, weighing over 50 kg (110 lbs), and no significant medical conditions or abnormal test results.

Inclusion Criteria

Generally healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate, and standard 12-lead electrocardiogram (ECG)

Body Mass Index (BMI) of 16-30 kilograms per meter squared, inclusive, and a total body weight greater than 50 kilograms (110 pounds)

Exclusion Criteria

I have or had a serious medical condition.

Specified abnormalities in safety assessments at Screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive single doses of PF-08642534 with and without itraconazole

4 weeks

Staying in the study clinic

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Itraconazole
• PF-08642534

Trial Overview

The study tests if itraconazole affects how the body processes PF-08642534. Participants receive single doses of PF-08642534 both with and without itraconazole in a controlled setting.

How Is the Trial Designed?

Group I: Period 2--itraconazole plus PF-08642534 Experimental Treatment 2 Interventions

Participants will receive single doses of PF-08642534) in presence of itraconazole.

Group II: Period 1--PF-08642534 Experimental Treatment 1 Intervention

Participants will receive a single dose of PF-08642534

Who Is Running the Clinical Trial?

Pfizer

Lead Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

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

1.

withpower.com

withpower.com/trial/phase-1-healthy-subjects-hs-4-2026-0ef1d

Itraconazole for Drug Interaction Study · Info for Participants

The purpose of this study is to learn if a medicine called itraconazole changes how the body processes the study medicine (PF-08642534) in ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41757749/

A Phase 1 Study in Healthy Participants

The aim of this phase 1 drug-drug interaction (DDI) study was to assess the effect of the strong CYP3A4 inhibitor itraconazole on the pharmacokinetics (PK) ...

3.

withpower.com

withpower.com/trial/phase-1-healthy-adult-participants-2026-a0890

Itraconazole for Drug Interaction Study · Info for Participants

This trial aims to understand how itraconazole affects the body's processing of another drug, PF-07248144, an experimental treatment.

4.

aesnet.org

aesnet.org/abstractslisting/effects-of-itraconazole--mefenamic-acid-and-rifampicin-on-the-pharmacokinetics-of-the-ch24h-inhibitor-soticlestat--two-drug%E2%80%93drug-interaction-studies-in-healthy-volunteers

Effects-of-Itraconazole--Mefenamic-Acid-and-Rifampicin-on ...

Two studies have assessed the effects of itraconazole (strong CYP3A inhibitor), mefenamic acid (MA; strong UGT1A9 inhibitor) and rifampicin ( ...

5.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2024/208901s004lbl.pdf

HIGHLIGHTS OF PRESCRIBING INFO - accessdata.fda.gov

Results of these two studies demonstrated substantial evidence of the effectiveness of itraconazole for the treatment of histoplasmosis, compared with the ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3250854/

Itraconazole: Precautions regarding drug interactions and ...

The interaction with rifampin may be problematic in aids patients, who frequently have concurrent mycobacterial and fungal infections. The interaction with ...

7.

go.drugbank.com

go.drugbank.com/drugs/DB01167

Itraconazole: Uses, Interactions, Mechanism of Action

Itraconazole is a triazole antifungal agent used to treat various fungal infections, such as blastomycosis and onychomycosis. Brand Names. Sporanox, Tolsura.

8.

drugs.com

drugs.com/drug-interactions/itraconazole.html

Itraconazole Interactions Checker

There are 586 drugs known to interact with itraconazole, along with 7 disease interactions, and 1 alcohol/food interaction. Of the total drug interactions, 259 ...

9.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2024/020657s042lbl.pdf

SPORANOX® (itraconazole) Oral Solution BOXED WARNING ...

Interaction Potential: SPORANOX® has a potential for clinically important drug interactions. Coadministration of specific drugs with itraconazole may result in ...