The purpose of this study is to learn how Itraconazole affects the blood level of PF-07817883 in Healthy Adults.
This study is seeking participants who are:
male and female aged 18 to 65 years old,
overtly healthy. This can be determined my medical evaluation, medical history, lab tests etc.
This study will consist of 2 parts, Period 1 and Period 2.
Period 1: participants will take PF-07817883 one time by mouth at the study clinic.
Period 2: participants will take PF-07817883 one time by mouth at the study clinic. They will also take daily itraconazole by mouth for 7 days.
Participants will stay at the study clinic for 2 weeks in total. The study doctors will collect blood and urine samples from everyone. The study doctors will check participants’ reactions to the study medicine for safety measures. There is a follow-up call at 28 to 35 days from the last dose of PF-07817883.
Itraconazole is an approved medicine. It is also a metabolism inhibitor. When taken with some medicines, it affects the actual level of these medicines in the body. This study will compare blood levels of PF-07817883 given with and without Itraconazole. This will help decide safety and right amount for PF-07817883 when given with metabolism inhibitors.
Detailed Description:
This is a Phase 1, open-label, 2-period, fixed sequence study to estimate the effect of itraconazole, a strong CYP3A4 inhibitor, on the plasma PK of PF-07817883 in healthy adults. The study will consist of 2 treatments: a single oral dose of PF-07817883 alone and a single oral dose of PF-07817883 in combination with multiple oral doses of itraconazole. The PK and safety will be assessed and compared for single dose of PF-07817883 in period 1 and period 2.
Source: View full study details on ClinicalTrials.gov
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