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Active, Not Recruiting

NCT Number: NCT07575945

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Healthy Participant

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

New Haven Clinical Research Unit

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 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

Treatment and study plan

PF-08642534

Drug

Participants will receive a single dose of PF-08642534

Itraconazole

Drug

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

Primary outcomes

  1. PF-08642534 Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)

    Time frame: 0 to 240 hours post-dose

Secondary outcomes

  1. Incidence of treatment-emergent Adverse Events

    Time frame: Baseline up to approximately 8 weeks

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 8, 2026
Registry last updated
Jun 15, 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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