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A Study to Learn if a Medicine Called Itraconazole Changes How the Body Processes the Study Medicine PF-08642534 in Healthy Adults.

A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO EVALUATE THE EFFECT OF ITRACONAZOLE ON THE PHARMACOKINETICS OF SINGLE ORAL DOSES OF PF-08642534 IN HEALTHY ADULT PARTICIPANTS

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07575945
Enrollment
14
Registered
2026-05-08
Start date
2026-05-05
Completion date
2026-07-23
Last updated
2026-08-21

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

Conditions

Healthy Participant

Brief summary

The purpose of this study is to learn if a medicine called itraconazole changes how the body processes the study medicine (PF-08642534) in healthy adults. This study is seeking healthy participants (men or women) who: * are aged 18 to 65 years of age * are confirmed to be healthy by their medical history and medical tests * have body mass index (BMI) of 16 to 30 kilograms per meter squared * have a total body weight of more than 50 kilograms. Participants will receive single doses of the study medicine (PF-08642534) with and without itraconazole. The total planned time of participation is about 12 weeks. The study consists of: * a screening period of up to 28 days before taking study drug * about 4 weeks of staying in the study clinic * a follow-up contact that will occur 28 to 35 days after taking itraconazole the last time.

Interventions

Participants will receive a single dose of PF-08642534

DRUGItraconazole

Participants will receive itraconazole once daily for 13 days (Day 12 to Day 24)

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 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Generally healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, blood pressure, pulse rate and standard 12-lead electrocardiogram (ECG). * Body Mass Index (BMI) of 16-30 kilograms per meter squared, inclusive, and a total body weight greater than 50 kilograms (110 pounds).

Exclusion criteria

* Evidence or history of clinically significant disease * Specified abnormalities in safety assessments at Screening

Design outcomes

Primary

MeasureTime frame
PF-08642534 Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)0 to 240 hours post-dose

Secondary

MeasureTime frame
Incidence of treatment-emergent Adverse EventsBaseline up to approximately 8 weeks

Countries

United States

Contacts

STUDY_DIRECTORPfizer CT.gov Call Center

Pfizer

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026