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
Pfizer
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
- Age range
- 18–65 years
- Sex
- All
- 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
Interventions
- DrugPF-08642534
Participants will receive a single dose of PF-08642534
- DrugItraconazole
Participants will receive itraconazole once daily for 13 days (Day 12 to Day 24)
Location
- New Haven Clinical Research UnitNew Haven, Connecticut