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A Study to Learn About How Itraconazole Affects the Blood Level of Study Medicine (PF-07817883) in Healthy Adults.

NCT05822440 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-10-04

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

PF-07817883

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

DRUG

Itraconazole

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-13
Primary Completion
2023-07-10
Completion
2023-07-10
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05822440 on ClinicalTrials.gov