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Period 1 for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up period 2 day 4 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours after pf-07817883 dose
Awards & highlights

Study Summary

This trial aims to learn how Itraconazole affects the blood level of PF-07817883 when taken with healthy adults. Participants will take PF-07817883 one time and Itraconazole for 7 days. Blood and urine samples will be taken.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~period 2 day 4 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours after pf-07817883 dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and period 2 day 4 pre-dose, 0.5, 1, 1.5, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours after pf-07817883 dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
AUC ratio of PF-07817883 alone vs coadministration with itraconazole
Cmax ratio of PF-07817883 alone vs coadministration with itraconazole
Secondary outcome measures
Apparent Oral Clearance (CL/F) of PF-07817883, when administered alone
Apparent Oral Clearance (CL/F) of PF-07817883, when administered with itraconazole
Apparent Volume of Distribution (Vz/F) of PF-07817883, when administered alone
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Period 2Experimental Treatment2 Interventions
This treatment arm includes 7-day dosing of itraconazole with a single dose of PF-07817883 Co-administered on Day 4 (Period 2 Day 4)
Group II: Period 1Experimental Treatment1 Intervention
The treatment arm includes a single dose of PF-07817883 (Period 1 Day 1)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Itraconazole
2017
Completed Phase 2
~780
PF-07817883
2022
Completed Phase 2
~350

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,862 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,093,030 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does participation in Phase 1 of the study present any health hazards to participants?

"Our internal evaluations put the safety of Period 1 at a score of 1, as there is only minimal clinical data available to support its efficacy and security."

Answered by AI

Do I meet the requirements to partake in this research?

"In order to be considered for inclusion in this medical trial, participants should have a healthy bill of health and must fall within the age bracket of 18-65 years old. The study is currently seeking 12 individuals."

Answered by AI

Are individuals aged 85 or younger suitable candidates for this clinical trial?

"This particular trial is limited to participants aged 18-65. Alternatively, there are 56 trials available for people under the age of majority and 364 studies accessible for seniors above 65 years old."

Answered by AI

Is recruitment still open for this experimental research?

"According to the details listed on clinicaltrials.gov, this study has opened up recruitment and is actively seeking patients. The trial was initially posted April 13th 2023 and last updated May 1st of that same year."

Answered by AI

How many individuals are presently signed up for this clinical experiment?

"Confirmed, the information on clinicaltrials.gov demonstrates that this study is actively recruiting participants. This trial was first posted in April 13th 2023 and has since been modified for the last time on May 1st of the same year. There are 12 spots open across one location."

Answered by AI

What is the purpose of this clinical research endeavor?

"The primary outcome that will be examined over the 0 to 96 hours post PF-07817883 window is a comparison between administering PF-0871783 alone and coadministering it with itraconazole. Amongst other secondary objectives, clinicians are assessing participants' physical condition, plasma decay half-life of this drug in combination with its partner compound, as well as determining an apparent volume of distribution via oral dosage."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Learn About How Itraconazole Affects the Blood Level of Study Medicine (PF-07817883) in Healthy Adults.
2023. "A Study to Learn About How Itraconazole Affects the Blood Level of Study Medicine (PF-07817883) in Healthy Adults.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05822440.
~6 spots leftby Apr 2025
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