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Completed

NCT Number: NCT07636018

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

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.

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Key information

Conditions

Healthy Adults

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - Brussels

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-07248144

Drug

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

Fluconazole

Drug

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

Primary outcomes

  1. Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) of PF-07248144 - Period 1

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose

  2. AUCinf of PF-07248144 - Period 2

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose

  3. Maximum Observed Plasma Concentration (Cmax) of PF-07248144 - Period 1

    Time frame: Pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose

  4. Cmax of PF-07248144 - Period 2

    Time frame: 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

  1. Number of Treatment-Emergent Adverse Events (AE) by Severity

    Time frame: 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).

  2. Number of Participants With Clinically Significant Clinical Laboratories Abnormalities

    Time frame: 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).

  3. Number of Participants With Clinically Significant Change From Baseline in Blood Pressure or Heart Rate

    Time frame: From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days)

  4. Number of Participants With Abnormalities in Physical Examination

    Time frame: From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days)

  5. Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Findings

    Time frame: From Baseline up to Period 2 Day 14 (Period 2 is up to 48 days)

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 9, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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