PF-07817883 Dose 4 in PART-1 for Healthy Subjects

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Healthy SubjectsPF-07817883 - Drug
Eligibility
18 - 60
All Sexes
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Study Summary

The purpose of this clinical trial is to learn if the study medicine (called PF-07817883) is safe and how it goes in and out of the body in healthy people. PF-07817883 is for the potential treatment of COVID-19. Participants will take PF-07817883 by mouth up to 2 times a day. This study may also evaluate how much PF-07817883 gets into the body when taken as pill. We may study if people's diets can affect this study medicine. We may also examine how PF-07817883 is processed and removed by the human body. Finally, we may look into if PF-07817883 has potential to interact with midazolam.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

14 Primary · 84 Secondary · Reporting Duration: Day 10 Pre-dose (0 hours) to 12 hours

Day 1
AUCtau[dn] on Day 1 in PART-2:MAD
Area Under the Curve from Time Zero to end of dosing interval (AUCtau) on Day 1 in PART-2:MAD
Average concentration (Cav) on Day 1 in PART-2:MAD
Cmax on Day 1 in PART-2:MAD
Cmax[dn] on Day 1 in PART-2:MAD
Tmax on Day 1 in PART-2:MAD
Day 11
Number of Participants With Clinically Significant Change From Baseline in Vital Signs in Optional PART-4:ME
Number of Participants With Laboratory Abnormalities in Optional PART-4:ME
Electrocardiogram
Number of participants with TEAEs in Optional PART-4:ME
Total % cumulative recovery of drug related material in feces combined in Optional PART-4: Metabolism and Excretion (ME)
Total % cumulative recovery of drug related material in urine and feces combined in Optional PART-4: Metabolism and Excretion (ME)
Brain Diseases, Metabolic
Day 12
Number of Participants With Clinically Significant Change From Baseline in Vital Signs in Optional PART-5:DDI
Number of Participants With Clinically Significant Change From Baseline in Vital Signs in PART-2:MAD
Number of Participants With Laboratory Abnormalities in Optional PART-5:DDI
Number of Participants With Laboratory Abnormalities in PART-2:MAD
Electrocardiogram
Electrocardiogram
Number of participants with TEAEs in Optional PART-5:DDI
Therapeutic procedure
Midazolam
Day 3
AUCinf in Optional PART-3:RBA/FE
AUCinf of midazolam, when administered alone, in Optional PART-5:DDI
AUCinf of midazolam, when administered with PF-07817883, in Optional PART-5:DDI
Iron
Midazolam
Midazolam
CL/F in Optional PART-3:RBA/FE
Midazolam
Midazolam
Cmax in Optional PART-3:RBA/FE
Midazolam
Midazolam
Number of Participants With Clinically Significant Change From Baseline in Vital Signs in Optional PART-3:RBA/FE
Number of Participants With Laboratory Abnormalities in Optional PART-3:RBA/FE
Electrocardiogram
Number of participants with TEAEs in Optional PART-3:RBA/FE
Iron
The ratio of AUClast in Optional PART-3:RBA/FE
The ratio of AUClast in Optional PART-3:relative bioavailability (RBA)/food effect (FE)
The ratio of Cmax in Optional PART-3:RBA/FE
The ratio of Cmax in Optional PART-3:relative bioavailability (RBA)/food effect (FE)
Tmax in Optional PART-3:RBA/FE
Midazolam
Midazolam
Vz/F in Optional PART-3:RBA/FE
Midazolam
Midazolam
t1/2 in Optional PART-3:RBA/FE
Day 4
AUCinf in Optional PART-4:ME
AUClast in Optional PART-4:ME
CL/F in Optional PART-4:ME
Cmax in Optional PART-4:ME
Tmax in Optional PART-4:ME
Vz/F in Optional PART-4:ME
t1/2 in Optional PART-4:ME
Day 5
Seasonal Affective Disorder
Seasonal Affective Disorder
Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) in PART-1:SAD
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) in PART-1:SAD
Dose Normalized AUClast (AUClast[dn]) in PART-1:SAD
Dose Normalized Cmax (Cmax[dn]) in PART-1:SAD
Dose normalized AUCinf (AUCinf[dn]) in PART-1:SAD
Seasonal Affective Disorder
Seasonal Affective Disorder
Seasonal Affective Disorder
Electrocardiogram
Seasonal Affective Disorder
Seasonal Affective Disorder
Seasonal Affective Disorder
Day 10
AUCtau on Day 10 in PART-2:MAD
AUCtau[dn] on Day 10 in PART-2:MAD
C12 on Day 10 in PART-2:MAD
CL/F on Day 10 in PART-2:MAD
Cav on Day 10 in PART-2:MAD
Cmax on Day 10 in PART-2:MAD
Cmax[dn] on Day 10 in PART-2:MAD
Cumulative Amount of Drug Recovered Unchanged in Urine From Time 0 to the Dosing Interval tau Hours Post-Dose (Aetau) on Day 10 in PART-2:MAD
PTR Day 10 in PART-2:MAD
Percentage of Dose Recovered Unchanged in Urine From Time 0 to the Dosing Interval tau Hours Post-Dose (Aetau%) on Day 10 in PART-2:MAD
Rac,Cmax on Day 10 in PART-2:MAD
Renal Clearance (Clr) on Day 10 in MAD
Tmax on Day 10 in PART-2:MAD
Day 12
Vz/F on Day 10 in PART-2:MAD
t1/2 on Day 10 in PART-2:MAD
Day 5
AUCtau on Day 5 in PART-2:MAD
AUCtau[dn] on Day 5 in PART-2:MAD
Average concentration (Cav) on Day 5 in PART-2:MAD
CL/F on Day 5 in PART-2:MAD
Cmax on Day 5 in PART-2:MAD
Cmax[dn] on Day 5 in PART-2:MAD
Polidocanol
Observed Accumulation Ratio Based on Cmax (Rac,Cmax) on Day 5 in PART-2:MAD
Peak Trough Ratio (PTR) Day 5 in PART-2:MAD
Tmax on Day 5 in PART-2:MAD
Day 5
Observed Accumulation Ratio Based on AUC (Rac) on Day 5 in PART-2:MAD
Rac on Day 10 in PART-2:MAD

Trial Safety

Safety Progress

1 of 3

Trial Design

22 Treatment Groups

PF-07817883 Dose 4 in PART-1
1 of 22
PF-07817883 DR4 in PART-2
1 of 22
PF-07817883 Dose 1 in PART-1
1 of 22
PF-07817883 in PART-4
1 of 22
PF-07817883 FORM-2 Fed in PART-3
1 of 22
PF-07817883 FORM-1 Fasted in PART-3
1 of 22
PF-07817883 Dose 3 in PART-1
1 of 22
PF-07817883 DR3 in PART-2
1 of 22
Midazolam 5 mg in PART-5
1 of 22
PF-07817883 Suspension Fasted in PART-3
1 of 22
PF-07817883 DR1 in PART-2
1 of 22
PF-07817883 DR2 in PART-2
1 of 22
PF-07817883 Dose 2 in PART-1
1 of 22
PF-07817883 in Chinese in PART-2
1 of 22
PF-07817883 Dose 5 in PART-1
1 of 22
PF-07817883 Dose 6 in PART-1
1 of 22
PF-07817883 FORM-1 Fed in PART-3
1 of 22
PF-07817883 in Japanese in PART-2
1 of 22
PF-07817883 FORM-2 Fasted in PART-3
1 of 22
Midazolam 5 mg with PF-07817883 in PART-5
1 of 22
Placebo in PART-2
1 of 22
Placebo in PART-1
1 of 22

Experimental Treatment

Non-Treatment Group

90 Total Participants · 22 Treatment Groups

Primary Treatment: PF-07817883 Dose 4 in PART-1 · Has Placebo Group · Phase 1

PF-07817883 Dose 4 in PART-1
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 DR4 in PART-2
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 Dose 1 in PART-1
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 in PART-4
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 FORM-2 Fed in PART-3
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 FORM-1 Fasted in PART-3
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 Dose 3 in PART-1
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 DR3 in PART-2
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
Midazolam 5 mg in PART-5
Drug
Experimental Group · 1 Intervention: Midazolam · Intervention Types: Drug
PF-07817883 Suspension Fasted in PART-3
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 DR1 in PART-2
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 DR2 in PART-2
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 Dose 2 in PART-1
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 in Chinese in PART-2
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 Dose 5 in PART-1
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 Dose 6 in PART-1
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 FORM-1 Fed in PART-3
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 in Japanese in PART-2
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
PF-07817883 FORM-2 Fasted in PART-3
Drug
Experimental Group · 1 Intervention: PF-07817883 · Intervention Types: Drug
Midazolam 5 mg with PF-07817883 in PART-5Experimental Group · 2 Interventions: PF-07817883, Midazolam · Intervention Types: Drug, Drug
Placebo in PART-2
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Placebo in PART-1
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Midazolam
2018
Completed Phase 4
~1920

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 10 pre-dose (0 hours) to 12 hours

Who is running the clinical trial?

PfizerLead Sponsor
4,303 Previous Clinical Trials
7,145,425 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,277 Previous Clinical Trials
4,855,331 Total Patients Enrolled

Eligibility Criteria

Age 18 - 60 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are > 18 years old and have a body mass index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight > 50 kg (110 lbs).
You are a healthy male or female between ages of 18-60 years.
You are a Chinese born in mainland China and both parents are of the Chinese descent.