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Antiviral

PF-07817883 in Japanese in PART-2 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 between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 10 pre-dose (0 hours) to 12 hours

Summary

This trial tests a new COVID-19 medicine called PF-07817883 in healthy people. It aims to see if the medicine is safe and how it moves through the body. The study also looks at how food and other drugs might affect the medicine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 10 pre-dose (0 hours) to 12 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 10 pre-dose (0 hours) to 12 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Seasonal Affective Disorder
Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-2:MAD
Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-6:SE
+15 more
Secondary study objectives
AUCinf in PART-3:RBA/FE
AUCinf in PART-4:ME
AUCinf in PART-6:SE
+65 more

Trial Design

25Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: PF-07817883 in PART-6Experimental Treatment1 Intervention
A single dose at supratherapeutic exposure administered as divided doses (1h apart)
Group II: PF-07817883 in PART-4Experimental Treatment1 Intervention
PART-4 is optional
Group III: PF-07817883 in Japanese in PART-2Experimental Treatment1 Intervention
Optional dosing regimen to be studied in Japanese population
Group IV: PF-07817883 in Chinese in PART-2Experimental Treatment1 Intervention
Optional dosing regimen to be studied in Chinese population
Group V: PF-07817883 Suspension Fasted in PART-3Experimental Treatment1 Intervention
PART-3 is optional
Group VI: PF-07817883 FORM-2 Fed in PART-3Experimental Treatment1 Intervention
Group VII: PF-07817883 FORM-2 Fasted in PART-3Experimental Treatment1 Intervention
Second solid oral formulations (FORM-2) is optional
Group VIII: PF-07817883 FORM-1 Fed in PART-3Experimental Treatment1 Intervention
Group IX: PF-07817883 FORM-1 Fasted in PART-3Experimental Treatment1 Intervention
First solid oral formulation (FORM1)
Group X: PF-07817883 Dose 6 in PART-1Experimental Treatment1 Intervention
Optional dose levels
Group XI: PF-07817883 Dose 5 in PART-1Experimental Treatment1 Intervention
Optional dose levels
Group XII: PF-07817883 Dose 4 in PART-1Experimental Treatment1 Intervention
Group XIII: PF-07817883 Dose 3 in PART-1Experimental Treatment1 Intervention
Group XIV: PF-07817883 Dose 2 in PART-1Experimental Treatment1 Intervention
Group XV: PF-07817883 Dose 1 in PART-1Experimental Treatment1 Intervention
Group XVI: PF-07817883 DR4 in PART-2Experimental Treatment1 Intervention
Optional dosing regimen
Group XVII: PF-07817883 DR3 in PART-2Experimental Treatment1 Intervention
Optional dosing regimen
Group XVIII: PF-07817883 DR2 in PART-2Experimental Treatment1 Intervention
Group XIX: PF-07817883 DR1 in PART-2Experimental Treatment1 Intervention
DR=Dosing regimen; twice a day
Group XX: Midazolam 5 mg with PF-07817883 in PART-5Experimental Treatment2 Interventions
Single dose of 5 mg on Day 10 with multiple doses (twice a day) of PF-07817883
Group XXI: Midazolam 5 mg in PART-5Experimental Treatment1 Intervention
Single dose of 5 mg alone
Group XXII: Moxifloxacin 400 mg in PART-6 (open label)Active Control2 Interventions
Moxifloxacin 400 mg at 0h followed by placebo at 1h
Group XXIII: Placebo in PART-2Placebo Group1 Intervention
Group XXIV: Placebo in PART-6Placebo Group1 Intervention
A single dose of placebo administered as divided doses (1h apart)
Group XXV: Placebo in PART-1Placebo Group1 Intervention
A single dose of placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
2018
Completed Phase 4
~1910
PF-07817883
2022
Completed Phase 2
~370

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

PfizerLead Sponsor
4,658 Previous Clinical Trials
17,877,193 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,544 Previous Clinical Trials
14,918,369 Total Patients Enrolled

Media Library

PF-07817883 (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT05580003 — Phase 1
Healthy Subjects Research Study Groups: PF-07817883 in Japanese in PART-2, PF-07817883 DR4 in PART-2, PF-07817883 FORM-2 Fed in PART-3, Midazolam 5 mg in PART-5, PF-07817883 in Chinese in PART-2, PF-07817883 FORM-2 Fasted in PART-3, Moxifloxacin 400 mg in PART-6 (open label), PF-07817883 DR3 in PART-2, Placebo in PART-2, PF-07817883 in PART-6, PF-07817883 Suspension Fasted in PART-3, PF-07817883 FORM-1 Fasted in PART-3, PF-07817883 FORM-1 Fed in PART-3, PF-07817883 in PART-4, Midazolam 5 mg with PF-07817883 in PART-5, Placebo in PART-6, PF-07817883 Dose 1 in PART-1, PF-07817883 Dose 2 in PART-1, PF-07817883 Dose 3 in PART-1, PF-07817883 Dose 4 in PART-1, PF-07817883 Dose 5 in PART-1, PF-07817883 Dose 6 in PART-1, Placebo in PART-1, PF-07817883 DR1 in PART-2, PF-07817883 DR2 in PART-2
Healthy Subjects Clinical Trial 2023: PF-07817883 Highlights & Side Effects. Trial Name: NCT05580003 — Phase 1
PF-07817883 (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05580003 — Phase 1
~30 spots leftby Nov 2025
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