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Active, Not Recruiting

NCT Number: NCT07335419

A Study to Learn if Itraconazole Changes How the Body Processes PF-07248144 (Study Medicine)

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

Itraconazole 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 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 itraconazole.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion

  • Female of nonchildbearing potential or males with 18 years of age or older, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and 12-lead electrocardiograms
  • Body mass index 18-32 kg/m2
  • Total body weight >50 kg (110 lb)

Exclusion

  • Pregnant female participants; breastfeeding female participants; female participants of childbearing potential; fertile male participants who are unwilling or unable to use highly effective methods of contraception as outlined in this protocol for the duration of the study and for at least 103 days after the last dose of study intervention
  • Use of 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
  • Any prior use of epigenetic modifying agents
  • Current use or anticipated need for food or drugs that are known moderate or strong inducers or inhibitors of CYP2C9 or CYP3A4, including their administration within 14 days or 5 half-lives of the strong inducers or inhibitors of CYP2C9 or CYP3A4, whichever is longer, prior to first dose of study intervention, during the treatment period, and within 10 days after the last dose of PF-07248144

Treatment and study plan

PF-07248144

Drug

Participants will receive PF-07248144 as a single dose, oral tablet on Day 1 of Period 1 and Day 4 of Period 2 with a washout period between two doses

Itraconazole

Drug

Participants will receive Itraconazole oral solution once daily on Days 1-12 in Period 2

Primary outcomes

  1. Area under the concentration-time curve from time zero to extrapolated infinite time (AUCinf) for PF-07248144

    Time frame: 0 (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. Area under the concentration-time curve from time zero to time of last measurable concentration (AUClast) for PF-07248144

    Time frame: 0 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose

    AUClast will be used as the primary endpoint if AUCinf cannot be reliably estimated

  3. Maximum observed plasma concentration (Cmax) for PF-07248144

    Time frame: 0 (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 participants with treatment-emergent adverse events

    Time frame: From baseline up to 28 to 35 days post last study intervention dose

  2. Number of participants with laboratory test abnormalities

    Time frame: From baseline up to 28 to 35 days post last study intervention dose

  3. Number of participants with vital signs values meeting categorical summarization criteria

    Time frame: From baseline up to 28 to 35 days post last study intervention dose

  4. Number of participants with clinically significant physical examination abnormalities

    Time frame: From baseline up to 28 to 35 days post last study intervention dose

  5. Number of participants with treatment emergent clinically significant abnormal electrocardiogram (ECG) measurements

    Time frame: From baseline up to 28 to 35 days post last study intervention dose

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2026
Registry last updated
Mar 19, 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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