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

NCT07636018 | Completed Phase 1

• 2 other identifiers: C45510102025-521924-31-00
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Adults

Keywords

PF-07248144; Fluconazole; DDI; Drug-Drug Interaction

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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)

Study Arms (1)

PF-07248144

EXPERIMENTAL

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; Drug: Fluconazole

Interventions

PF-07248144 DRUG

PF-07248144 administered by mouth as a single dose in Period 1 and Period 2.

PF-07248144

Fluconazole DRUG

Fluconazole administered by mouth once a day for 13 days in Period 2.

PF-07248144

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - Brussels

Brussels, Bruxelles-capitale, Région de, B-1070, Belgium

Location

Related Links

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

MeSH Terms

Interventions

Fluconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: June 9, 2026
• Study Start: August 26, 2025
• Primary Completion: October 8, 2025
• Study Completion: November 4, 2025
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)