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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
Awards & highlights

Study Summary

This trial tests if a potential COVID-19 medicine (PF-07817883) is safe and how it is processed by the body. It may also look into if diet affects the medicine and if it interacts with midazolam.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
AUCinf in PART-3:RBA/FE
AUCinf in PART-4:ME
AUCinf in PART-6:SE
+86 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
~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
10,911,780 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,948 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

Frequently Asked Questions

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

What is the highest possible participant count in this clinical trial?

"Affirmative. Data found on clinicaltrials.gov shows that this medical study is currently recruiting patients, and was initially published on October 17th 2022 with the newest update occurring a week later on October 27th 2022. The goal of this trial is to enroll 90 participants at one experimental site."

Answered by AI

Are there still vacancies for participants in this experiment?

"Clinicaltrials.gov notes that recruitment for this trial remains open, with the initial posting being issued on October 17th 2022 and last updated a few weeks later on October 27th of the same year."

Answered by AI

Has the FDA accepted PF-07817883 Dose 2 for use in PART-1?

"With limited data available to attest to its efficacy and safety, PF-07817883 Dose 2 in PART-1 received a score of 1 on our team's scale at Power."

Answered by AI

To what extent is eligibility for this study restricted?

"This trial seeks 90 volunteers aged 18 to 60 with a healthy status (HS), BMI between 17.5 and 30.5kg/m2, and bodyweight above 50 kilograms (110 pounds). Lower weights can be considered for certain cases. The protocol is applicable for both genders in part-4, though male participants are exclusively sought after. Additionally, Japanese people born from four biologic grandparents native to Japan as well as Chinese individuals born of two parents within mainland China are welcome to participate."

Answered by AI

Is this clinical trial open to persons aged 20 and over?

"According to the established parameters for participating in this experiment, individuals must be between 18 and 60 years of age. Separate clinical trials are available for those under 18 or over 65."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People
2022. "A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05580003.
~38 spots leftby Apr 2025
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