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

Pfizer

Status and phase: Enrolling; Phase 1

Conditions: Healthy Adult Participants

Treatments: Drug: Itraconazole; Drug: PF-07248144

Study type: Interventional

Funder types: Industry

Identifiers

NCT07335419

C4551006

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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12 participants in 1 patient group

PF-07248144 with and without Itraconazole

Experimental group

Description:

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

Treatment:

Drug: PF-07248144

Drug: Itraconazole