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

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

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07335419
Enrollment
12
Registered
2026-01-13
Start date
2026-01-02
Completion date
2026-03-21
Last updated
2026-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Adult Participants

Keywords

Itraconazole, PF-07248144, Drug-Drug Interaction (DDI)

Brief summary

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.

Interventions

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

DRUGItraconazole

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

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Area under the concentration-time curve from time zero to extrapolated infinite time (AUCinf) for PF-072481440 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-dose
Area under the concentration-time curve from time zero to time of last measurable concentration (AUClast) for PF-072481440 (pre-dose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours post-doseAUClast will be used as the primary endpoint if AUCinf cannot be reliably estimated
Maximum observed plasma concentration (Cmax) for PF-072481440 (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

MeasureTime frame
Number of participants with treatment-emergent adverse eventsFrom baseline up to 28 to 35 days post last study intervention dose
Number of participants with laboratory test abnormalitiesFrom baseline up to 28 to 35 days post last study intervention dose
Number of participants with vital signs values meeting categorical summarization criteriaFrom baseline up to 28 to 35 days post last study intervention dose
Number of participants with clinically significant physical examination abnormalitiesFrom baseline up to 28 to 35 days post last study intervention dose
Number of participants with treatment emergent clinically significant abnormal electrocardiogram (ECG) measurementsFrom baseline up to 28 to 35 days post last study intervention dose

Countries

United States

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026