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NCT07575945
A Study to Learn if a Medicine Called Itraconazole Changes How the Body Processes the Study Medicine PF-08642534 in Healthy Adults.
Conditions: Healthy Participant
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 14
Sponsor: Pfizer
Location: New Haven Clinical Research Unit New Haven Connecticut
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07575945). StuddyBuddy aggregates publicly available trial information.