Phase 1
Completed N=16
A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People
Healthy
Source: ClinicalTrials.gov NCT05580003 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) — 4; 1; 2; 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
4; 1; 2; 1; 0; 3 | — |
| PRIMARY Part 1: Number of Participants With Laboratory Test Abnormalities |
5; 1; 2; 2; 1; 1 | — |
| PRIMARY Part 1: Number of Participants With Vital Signs Meeting Pre-Defined Criteria |
0; 0; 0; 1; 1; 0 | — |
| PRIMARY Part 1: Number of Participants With Electrocardiogram (ECG) Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
2; 1; 0; 2; 0; 2 | — |
| PRIMARY Part 2: Number of Participants With Laboratory Test Abnormalities |
1; 2; 2; 2; 0; 1 | — |
| PRIMARY Part 2: Number of Participants With Vital Signs Meeting Pre-Defined Criteria |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part 2: Number of Participants With Electrocardiogram (ECG) Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Part 3:Ratio Based on Area Under Plasma Concentration Time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) and Area Under Concentration-Time Curve From Time 0 Extrapolated to Infinite Time (AUCinf) of Oral Formulation and Suspension |
42970; 44140; 28430; 42930; 46170; 42540 | — |
| PRIMARY Part 3: Ratio Based on Maximum Observed Concentration (Cmax) of Oral Formulation and Suspension |
9354; 6934; 4590; 6284; 5008 | — |
| PRIMARY Part 4: Percentage of Total Dose Administered Recovered in Urine |
12.6 | — |
| PRIMARY Part 4: Percentage of Total Dose Administered Recovered in Feces |
88.9 | — |
| PRIMARY Part 4: Percentage of Total Dose Administered Recovered in Urine and Feces |
101.5 | — |
| PRIMARY Part 5: Maximum Observed Concentration (Cmax) of Midazolam |
33.71; 30.20 | — |
| PRIMARY Part 5: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of Midazolam |
94.30; 79.85 | — |
| PRIMARY Part 6: Number of Participants With TEAEs |
4; 6; 4 | — |
| PRIMARY Part 6: Number of Participants With Laboratory Test Abnormalities |
12; 12; 7 | — |
| PRIMARY Part 6: Number of Participants With Vital Signs Meeting Pre-Defined Criteria |
1; 2; 3; 0; 1; 0 | — |
| PRIMARY Part 6: Number of Participants According to Categorization of ECG Data |
0; 0; 1; 0; 0; 1 | — |
| SECONDARY Part 1: Maximum Observed Concentration (Cmax) of PF-07817883 |
2269; 6235; 3223; 17420; 34420; 34670 | — |
| SECONDARY Part 1: Time for Cmax (Tmax) of PF-07817883 |
1.00; 0.792; 1.25; 0.500; 0.500; 1.00 | — |
| SECONDARY Part 1: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883 |
10890; 34580; 27080; 83490; 160700; 185700 | — |
| SECONDARY Part 1: Dose Normalized Cmax (Cmax[dn]) of PF-07817883 |
15.14; 12.48; 6.445; 11.61; 11.49; 8.672 | — |
| SECONDARY Part 1: Dose Normalized AUClast (AUClast[dn]) of PF-07817883 |
72.61; 69.17; 54.16; 55.64; 53.53; 46.43 | — |
| SECONDARY Part 1: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883 |
11250; 35950; 28120; 85320; 166100; 189400 | — |
| SECONDARY Part 1: Dose Normalized AUCinf (AUCinf[dn]) of PF-07817883 |
74.99; 71.81; 56.23; 56.86; 55.33; 47.34 | — |
| SECONDARY Part 1: Terminal Half-Life (t1/2) of PF-07817883 |
4.534; 13.88; 15.95; 10.84; 18.79; 13.05 | — |
| SECONDARY Part 1: Apparent Volume of Distribution (Vz/F) of PF-07817883 |
86.87; 209.5; 366.1; 242.9; 367.4; 358.7 | — |
| SECONDARY Part 1: Apparent Clearance (CL/F) of PF-07817883 |
13.33; 13.93; 17.79; 17.58; 18.09; 21.13 | — |
| SECONDARY Part 2: Maximum Observed Concentration (Cmax) of PF-07817883 on Days 1, 5 and 10 |
3582; 8470; 24100; 8381; 4234; 9112 | — |
| SECONDARY Part 2: Time for Cmax (Tmax) of PF-07817883 on Days 1, 5 and 10 |
0.759; 0.775; 0.500; 1.00; 0.859; 0.500 | — |
| SECONDARY Part 2: Area Under the Plasma Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) of PF-07817883 on Days 1, 5 and 10 |
14760; 36440; 108400; 36880; 18460; 36300 | — |
| SECONDARY Part 2: Concentration at 12 Hour Nominal Time Post-Dose (C12) of PF-07817883 on Days 5 and 10 |
389.3; 734.5; 2598; 716.0; 425.7; 865.9 | — |
| SECONDARY Part 2: Dose Normalized Cmax (Cmax[dn]) of PF-07817883 on Days 1, 5 and 10 |
17.93; 14.15; 16.07; 14.00; 21.18; 15.20 | — |
| SECONDARY Part 2: Dose Normalized AUCtau (AUCtau[dn]) of PF-07817883 on Days 1, 5 and 10 |
73.94; 60.70; 72.25; 61.44; 92.46; 60.49 | — |
| SECONDARY Part 2: Average Concentration (Cav) of PF-07817883 on Days 5 and 10 |
1542; 3022; 9515; 3140; 1434; 2914 | — |
| SECONDARY Part 2: Observed Accumulation Ratio for AUCtau (Rac) of PF-07817883 on Days 5 and 10 |
1.250; 0.9972; 1.054; 1.022; 1.163; 0.8962 | — |
| SECONDARY Part 2: Observed Accumulation Ratio for Cmax (Rac,Cmax) of PF-07817883 on Days 5 and 10 |
1.183; 1.075; 1.142; 0.9844; 0.9744; 0.8471 | — |
| SECONDARY Part 2: Peak-to-Trough Ratio (PTR) of PF-07817883 on Days 5 and 10 |
10.88; 13.47; 10.60; 13.22; 8.566; 11.05 | — |
| SECONDARY Part 2: Apparent Clearance (CL/F) of PF-07817883 on Days 5 and 10 |
10.83; 16.57; 13.12; 15.88; 11.60; 17.13 | — |
| SECONDARY Part 2: Apparent Volume of Distribution (Vz/F) of PF-07817883 on Day 10 |
200.1; 279.6; 198.1; 186.0 | — |
| SECONDARY Part 2: Terminal Half-Life (t1/2) of PF-07817883 on Day 10 |
13.95; 13.01; 11.44; 8.587 | — |
| SECONDARY Part 2: Amount Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau) of PF-07817883 on Day 10 |
18.47; 96.86; 373.2; 85.85 | — |
| SECONDARY Part 2: Percent of Dose Excreted in Urine as Unchanged Drug Over the Dosing Interval Tau (Aetau%) of PF-07817883 on Day 10 |
9.261; 16.15; 24.90; 14.34 | — |
| SECONDARY Part 2: Renal Clearance (CLr) of PF-07817883 on Day 10 |
1.074; 2.771; 3.586; 2.477 | — |
| SECONDARY Part 3: Ratio Based on AUClast and AUCinf of Tablet Formulation Under Fed Condition and Fasted Condition |
44140; 28430; 42930; 46170; 43570; 27750 | — |
| SECONDARY Part 3: Ratio Based on Maximum Observed Concentration (Cmax) of Tablet Formulation Under Fed Condition and Fasted Condition |
6934; 4590; 6284; 5008 | — |
| SECONDARY Part 3: Time for Cmax (Tmax) of PF-07817883 |
0.750; 1.01; 4.00; 1.34; 4.00 | — |
| SECONDARY Part 3: Maximum Observed Concentration (Cmax) of PF-07817883 |
9354; 6934; 4590; 6284; 5008 | — |
| SECONDARY Part 3: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883 |
42540; 43570; 27750; 41620; 35930 | — |
| SECONDARY Part 3: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883 |
42970; 44140; 28430; 42930; 46170 | — |
| SECONDARY Part 3: Terminal Half-Life (t1/2) of PF-07817883 |
7.578; 7.957; 10.15; 6.822; 11.07 | — |
| SECONDARY Part 3: Apparent Clearance (CL/F) of PF-07817883 |
13.97; 13.58; 21.09; 13.98; 12.98 | — |
| SECONDARY Part 3: Apparent Volume of Distribution (Vz/F) of PF-07817883 |
136.2; 136.7; 302.2; 120.7; 192.8 | — |
| SECONDARY Part 3: Number of Participants With TEAEs |
4; 1; 1; 4; 2 | — |
| SECONDARY Part 3: Number of Participants With Laboratory Test Abnormalities |
0; 0; 2; 0; 2 | — |
| SECONDARY Part 3: Number of Participants With Vital Signs Meeting Pre-Defined Criteria |
0; 0; 0; 0; 0 | — |
| SECONDARY Part 3: Number of Participants With ECG Abnormalities |
0; 0; 0; 0; 0 | — |
| SECONDARY Part 4: Time for Cmax (Tmax) of PF-07817883 |
0.500 | — |
| SECONDARY Part 4: Maximum Observed Concentration (Cmax) of PF-07817883 |
6791 | — |
| SECONDARY Part 4: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883 |
35520 | — |
| SECONDARY Part 4: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883 |
36910 | — |
| SECONDARY Part 4: Terminal Half-Life (t1/2) of PF-07817883 |
6.882 | — |
| SECONDARY Part 4: Apparent Clearance (CL/F) of PF-07817883 |
16.26 | — |
| SECONDARY Part 4: Apparent Volume of Distribution (Vz/F) of PF-07817883 |
146.7 | — |
| SECONDARY Part 4: Number of Participants With TEAEs |
4 | — |
| SECONDARY Part 4: Number of Participants With Laboratory Test Abnormalities |
1 | — |
| SECONDARY Part 4: Number of Participants With Vital Signs Meeting Pre-Defined Criteria |
1; 0; 0; 1; 0; 0 | — |
| SECONDARY Part 4: Number of Participants With ECG Abnormalities |
— | — |
| SECONDARY Part 5: Number of Participants With TEAEs |
11; 10 | — |
| SECONDARY Part 5: Number of Participants With Laboratory Test Abnormalities |
5; 2 | — |
| SECONDARY Part 5: Number of Participants With Vital Signs Meeting Pre-Defined Criteria |
3; 3; 0; 0; 0; 1 | — |
| SECONDARY Part 5: Number of Participants With ECG Abnormalities |
0; 0 | — |
| SECONDARY Part 5: Time for Cmax (Tmax) of Midazolam |
0.500; 0.500 | — |
| SECONDARY Part 5: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Midazolam |
92.37; 77.46 | — |
| SECONDARY Part 5: Terminal Half-Life (t1/2) of Midazolam |
6.589; 6.923 | — |
| SECONDARY Part 5: Apparent Clearance (CL/F) of Midazolam |
53.02; 62.60 | — |
| SECONDARY Part 5: Apparent Volume of Distribution (Vz/F) of Midazolam |
488.5; 598.9 | — |
| SECONDARY Part 6: Maximum Observed Concentration (Cmax) of PF-07817883 |
53160 | — |
| SECONDARY Part 6: Time for Cmax (Tmax) of PF-07817883 |
1.00 | — |
| SECONDARY Part 6: Area Under Plasma Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of PF-07817883 |
248300 | — |
| SECONDARY Part 6: Area Under the Concentration -Time Curve From Time Zero (0) Extrapolated to Infinite Time (AUCinf) of PF-07817883 |
253000 | — |
| SECONDARY Part 6: Terminal Half-Life (t1/2) of PF-07817883 |
12.64 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male or female subjects between ages of 18-60 years. Male only in part-4.
- Body Mass Index (BMI) of 17.5 to 30.5kg/m2; and a total body weight >50kg (110lbs). A body weight of >45 kg may be considered in selected cases.
- Japanese subjects who have four Japanese biologic grandparents born in Japan
- Chinese participants who were born in mainland China and both parents are of the Chinese descent.
Exclusion Criteria
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
- Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy, intestinal resection).
- Positive test result for SARS-CoV-2 infection at the time of screening or Day-1.
- Have received COVID-19 vaccine within 7 days before screening or have received only one of the 2 required doses of COVID-19 vaccine
- Use of tobacco or nicotine containing products in excess of the equivalents of 5 cigarettes per day or 2 chews of tobacco per day
- Use of prescription or nonprescription drugs and dietary and herbal supplements within 28 days or 5 half lives (whichever is longer) prior to the first dose of study intervention.
Data sourced from ClinicalTrials.gov (NCT05580003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.