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

NCT07335419 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: C4551006
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Adult Participants

Keywords

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

Outcome Measures

Primary Outcomes (3)

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

  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

• Area under the concentration-time curve from time zero to time of last measurable concentration (AUClast) for PF-07248144

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

  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

• Maximum observed plasma concentration (Cmax) for PF-07248144

  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 (5)

• Number of participants with treatment-emergent adverse events

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

• Number of participants with laboratory test abnormalities

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

• Number of participants with vital signs values meeting categorical summarization criteria

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

• Number of participants with clinically significant physical examination abnormalities

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

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

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

Study Arms (1)

PF-07248144 with and without Itraconazole

EXPERIMENTAL

Period 1; PF-07248144 single dose, oral tablet on Day 1. Period 2; Itraconazole oral solution once daily on Days 1-12 plus PF-07248144 single dose, oral tablet on Day 4. Period 1 and Period 2 will be separated with a washout of at least 14 days

Drug: PF-07248144; Drug: Itraconazole

Interventions

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

PF-07248144 with and without Itraconazole

Itraconazole DRUG

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

PF-07248144 with and without Itraconazole

Eligibility Criteria

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Clinical Research Unit - New Haven

New Haven, Connecticut, 06511, United States

Location

Related Links

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

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 13, 2026
• Study Start: January 2, 2026
• Primary Completion: February 22, 2026
• Study Completion: March 21, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)