CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 12 enrolled
Drug / intervention
PF-07817883 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05822440
NCT05822440Phase 1Completed

A Phase 1, Open-Label, 2-Period, Fixed Sequence Study to Estimate the Effect of Itraconazole on the Pharmacokinetics of PF-07817883 in Healthy Adults

Pfizer·interventional·Posted Apr 20, 2023·Updated Oct 4, 2024

In Brief

A Phase 1 clinical trial evaluating PF-07817883 and Itraconazole for Healthy. Completed, enrolled 12 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedApr 20, 2023
Enrollment StartApr 13, 2023
Primary CompletionJul 10, 2023
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 3.2 years ago

Interventions

PF-07817883drug

Single oral dose (period 1) or co-administered with itraconazole (period 2)

Itraconazoledrug

Interacting drug which will be given for 7 days in period 2