A Study to Learn if the Study Medicine Called Fluconazole Changes How the Other Body Processes the Study Medicine PF-07248144

A PHASE 1, OPEN-LABEL, FIXED SEQUENCE, 2-PERIOD, CROSSOVER STUDY IN HEALTHY PARTICIPANTS TO INVESTIGATE THE EFFECT OF FLUCONAZOLE ON PF-07248144 PHARMACOKINETICS

The purpose of the study is to learn how the study medicine called fluconazole changes how the body processes the other study medicine called PF-07248144. The study will also look at the safety, tolerability, and how the medicine is changed and removed from the body after taking PF-07248144 alone compared to when it is taken with fluconazole.

Fluconazole 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 up to 10 days 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 fluconazole.

Study Overview

• Status: Completed
• Conditions: Healthy Adults
• Intervention / Treatment: Drug: PF-07248144; Drug: Fluconazole

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles-capitale, Région de
    • Brussels, Bruxelles-capitale, Région de, Belgium, B-1070
      • Pfizer Clinical Research Unit - Brussels

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

• Male or female of nonchildbearing potential ≥ 18 years of age, inclusive, at screening who are overtly healthy as determined by medical evaluations including medical history, physical examination, laboratory tests, vital signs and 12-lead ECGs.
• Body mass index (BMI) of 18-32 kg/m2; and a total body weight >50 kg (110 lb).

Exclusion Criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
• Use prescription or nonprescription drugs and dietary and herbal supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-07248144; PF-07248144 administered by mouth as a single dose in Period 1 and Period 2. Fluconazole administered by mouth once a day for 13 days in Period 2.	Drug: PF-07248144; PF-07248144 administered by mouth as a single dose in Period 1 and Period 2.; Drug: Fluconazole; Fluconazole administered by mouth once a day for 13 days in Period 2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07248144 - Period 1	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
AUCinf of PF-07248144 - Period 2	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
Maximum Observed Plasma Concentration (Cmax) of PF-07248144 - Period 1	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
Cmax of PF-07248144 - Period 2	Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Treatment-Emergent Adverse Events (AE) by Severity	From Baseline through follow-up, up to 35 days after last dose of study drug in Period 2 (Period 2 is up to 48 days).
Number of Participants With Clinically Significant Clinical Laboratories Abnormalities	From Baseline through follow-up, up to 35 days after last dose of study drug in Period 2 (Period 2 is up to 48 days).
Number of Participants With Clinically Significant Change From Baseline in Blood Pressure or Heart Rate	From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days)
Number of Participants With Abnormalities in Physical Examination	From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days)
Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings	From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 26, 2025
• Primary Completion (Actual): October 8, 2025
• Study Completion (Actual): November 4, 2025

Study Registration Dates

• First Submitted: July 17, 2025
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Fluconazole; Drug-Drug Interaction; DDI; PF-07248144
• Additional Relevant MeSH Terms: Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Triazoles; Fluconazole
• Other Study ID Numbers: C4551010; 2025-521924-31-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No