Healthy
Conditions
Brief summary
The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) of single and multiple ascending oral doses of PF-07059013 in healthy adult participants. Additionally, effects of different formulations and food on parameters, including PK may be explored.
Interventions
DRUGPF-07059013
Participants will recieve PF-07059013
DRUGPlacebo
Participants will recieve placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and female (of non-child bearing potential) participants must be 18 to 55 years of age, inclusive, at the time of signing the ICD. 2. Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, including blood pressure, pulse rate, respiratory rate and temperature measurement, standard 12 lead ECG, laboratory tests, and cardiac monitoring (in Part 1 only). 3. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. Weight: 4. BMI of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lb). 5. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.
Exclusion criteria
1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing). 2. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). 3. History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing at screening for HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody (HCVAb). As an exception a positive HBsAb test due to hepatitis B vaccination is permissible. 4. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. 5. Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half lives (whichever is longer) prior to the first dose of study intervention. 6. Previous administration with an investigational drug within 30 days (or as determined by the local requirement) or 5 half lives preceding the first dose of study intervention used in this study (whichever is longer). 7. A positive urine drug test at screening or admission. 8. A positive urine cotinine test at screening or admission in Part 1 and 2. 9. Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest. If BP is ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), the BP should be repeated 2 more times and the average of the 3 BP values should be used to determine the participant's eligibility. 10. Baseline 12 lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results (eg, baseline QTc interval \>450 msec, complete left bundle branch block (LBBB), signs of an acute or indeterminate age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second or third degree atrioventricular (AV) block, or serious bradyarrhythmias or tachyarrhythmias). If the baseline uncorrected QT interval is \>450 msec, this interval should be rate corrected using the Fridericia method and the resulting QTcF should be used for decision making and reporting. If QTc exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTc or QRS values should be used to determine the participant's eligibility. Computer interpreted ECGs should be overread by a physician experienced in reading ECGs before excluding participants. 11. Participants with ANY of the following abnormalities in clinical laboratory tests at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary: * AST or ALT level ≥1.5 × ULN; * Total bilirubin level ≥1.5 × ULN; participants with a history of Gilbert's syndrome may have direct bilirubin measured and would be eligible for this study provided the direct bilirubin level is ≤ ULN; * PT/INR \>1.2 × ULN; * aPTT ≥1.5 × ULN; * Hemoglobin \<11.0 g/dL; * Lactate \>1 x ULN. 12. For Part 2 only, participants with absolute reticulocyte count \>150,000/uL at screening, as assessed by the study specific laboratory and confirmed by a single repeat test, if deemed necessary. 13. History of alcohol abuse or binge drinking and/or any other illicit drug use or dependence within 6 months of Screening. Binge drinking is defined as a pattern of 5 (male) and 4 (female) or more alcoholic drinks in about 2 hours. As a general rule, alcohol intake should not exceed 14 units per week (1 unit = 8 ounces (240 mL) beer, 1 ounce (30 mL) of 40% spirit or 3 ounces (90 mL) of wine). 14. Use of tobacco/nicotine containing products for Part 1 or 2, and use of more than 5 cigarettes/day for Part 3. 15. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to dosing. 16. Unwilling or unable to comply with the criteria in the Lifestyle Considerations section of this protocol. 17. Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2) | Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Treatment-related TEAEs were any untoward medical occurrence attributed to study intervention. Relatedness to study treatment was determined by the investigator. Duration of participation of Part 1 and Part 3, from the screening visit to the follow-up phone call, was approximately 15 weeks. Duration of participation of Part 2, from the screening visit to the follow-up phone call, was approximately 10 weeks. |
| Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Part 1: from Screening to Day 8; Part 2: from Screening to Day 21; Part 3: from Screening to Day 5. | Protocol-required safety laboratory assessments included chemistry, hematology, and urinalysis (and microscopy, if needed). Each parameter was evaluated against commonly used and widely accepted criteria. Laboratory test with abnormalities are reported. Evaluation activities as: Part 1: At Screening, Day -1, and Day 1 (at 8 hours post dose), 2, 5, 8. Part 2: At Screening, Day -1, 1, 2, 4, 7, 10, 14, 18, 21. Part 3: At Screening, Day -1, 2, 5. |
| Number of Participants With Vital Signs Findings of Potential Clinical Importance | Part 1: from Screening to Day 8; Part 2: from Screening to Day 21; Part 3: from Screening to Day 5. | Vital sign data included supine blood pressure, pulse rate, orthostatic blood pressure and oral temperature. Vital signs with abnormalities are reported. Evaluation activities as: Part 1: Supine blood pressure and pulse rate: At Screening, 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72, 96, and 168 hours post dose. Orthostatic blood pressure, respiratory rate and oral temperature: 0, 2, 8, and 24 hours post dose. Part 2: Supine blood pressure and pulse rate: At Screening, Day 1, 2, 4, 7, 10, 14, 15, 18, 21. Orthostatic blood pressure, respiratory rate and oral temperature: Day 1, 7, 14, 18. Part 3: Supine blood pressure and pulse rate: At Screening, 0, 2, 5, 8, 12, 24, 48, and 96 hours post dose. Respiratory rate and oral temperature: 0, 24 and 96 hours post dose. |
| Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | Part 1: from Screening to Day 8; Part 2: from Screening to Day 21; Part 3: from Screening to Day 5. | Clinical significance of 12-Lead ECG data was assessed by the investigator. ECG findings with abnormalities were reported. Evaluation activities as: Part 1: At Screening, 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72, 96, and 168 hours post dose. Part 2: At Screening, Day 1, 2, 4, 7, 10, 14, 15, 18, 21. Part 3: At Screening, 0, 2, 5, 8, 12, 24, 48, and 96 hours post dose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PF-07059013 Blood and Plasma Tmax of Part 2 | 0, 0.5, 1, 2, 4, 6, 8, 12 hours post dose on Day 1, 7, and 14. | PF-07059013 Blood and Plasma Tmax of Part 2 was evaluated. |
| PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | 0, 0.5, 1, 2, 4, 6, 8, 12 hours post dose on Day 1, 7, and 14. | PF-07059013 Blood and Plasma AUCtau (the Dosing Interval, Where Tau = 24 Hours for QD Dosing) for Part 2 was evaluated. |
| PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72 (period 2-4 only), 96 (period 2-4 only), and 168 hours post dose of each period. | PF-07059013 Blood and Plasma Cmax for Part 1 was evaluated. For Part 1, in period 1, participants were given PF-07059013 100 mg SD and PF-07059013 250 mg SD, all with polymer; in period 2, participants were given PF-07059013 500 mg SD and PF-07059013 1000 mg SD, all with polymer; in period 3, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all with polymer; in period 4, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all without polymer. |
| p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | Part 2: 0 and 8 hours post dose on Day 1, 7 and 14, and on Day 2, 15, 18. | p20 and p50 change from baseline in Part 2 was evaluated. |
| p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | Part 1: 0 and 8 hours post dose. | p20 and p50 change from baseline in Part 1 was evaluated. |
| PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72 (period 2-4 only), 96 (period 2-4 only), and 168 hours post dose of each period. | PF-07059013 Blood and Plasma Tmax for Part 1 was evaluated. For Part 1, in period 1, participants were given PF-07059013 100 mg SD and PF-07059013 250 mg SD, all with polymer; in period 2, participants were given PF-07059013 500 mg SD and PF-07059013 1000 mg SD, all with polymer; in period 3, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all with polymer; in period 4, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all without polymer. |
| PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72 (period 2-4 only), 96 (period 2-4 only), and 168 hours post dose of each period. | PF-07059013 Blood and Plasma AUClast of Part 1 was evaluated. For Part 1, in period 1, participants were given PF-07059013 100 mg SD and PF-07059013 250 mg SD, all with polymer; in period 2, participants were given PF-07059013 500 mg SD and PF-07059013 1000 mg SD, all with polymer; in period 3, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all with polymer; in period 4, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all without polymer. |
| PF-07059013 Blood and Plasma Cmax of Part 2 | 0, 0.5, 1, 2, 4, 6, 8, 12 hours post dose on Day 1, 7, and 14. | PF-07059013 Blood and Plasma Cmax of Part 2 was evaluated. |
Countries
Belgium
Participant flow
Pre-assignment details
A total of 61 participants were randomized in the study and all were treated with study intervention. For Part 1, a total of 21 participants were randomized and all were treated with at least 1 dose. For Part 2, a total of 35 participants were randomized and treated. For Part 3, a total of 5 participants were randomized and all were treated with at least 1 dose.
Participants by arm
| Arm | Count |
|---|---|
| A->D->F->H In Part 1, participants were given a single dose of study intervention assigned.
A-\>D-\>F-\>H: Placebo Single dose (SD) Polymer-\>PF-07059013 500 mg SD Polymer-\>PF-07059013 2000 mg SD Polymer-\>PF-07059013 2000 mg SD without (w/o) Polymer | 3 |
| A->E->G->I In Part 1, participants were given a single dose of study intervention assigned.
A-\>E-\>G-\>I: Placebo SD Polymer-\>PF-07059013 1000 mg SD Polymer-\>PF-07059013 3000 mg SD Polymer-\>PF-07059013 3000 mg SD w/o Polymer | 3 |
| B->A->F->H In Part 1, participants were given a single dose of study intervention assigned.
B-\>A-\>F-\>H: PF-07059013 100 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 2000 mg SD Polymer-\>PF-07059013 2000 mg SD w/o Polymer | 3 |
| B->D->A->H In Part 1, participants were given a single dose of study intervention assigned.
B-\>D-\>A-\>H: PF-07059013 100 mg SD Polymer-\>PF-07059013 500 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 2000 mg SD w/o Polymer | 3 |
| C->A->G->I In Part 1, participants were given a single dose of study intervention assigned.
C-\>A-\>G-\>I: PF-07059013 250 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 3000 mg SD Polymer-\>PF-07059013 3000 mg SD w/o Polymer | 5 |
| C->E->A->I In Part 1, participants were given a single dose of study intervention assigned.
C-\>E-\>A-\>I: PF-07059013 250 mg SD Polymer-\>PF-07059013 1000 mg SD Polymer-\>Placebo SD Polymer-\>PF-07059013 3000 mg SD w/o Polymer | 4 |
| Part 2: Placebo MD With Polymer In Part 2, participants were given multiple doses of study intervention QD for 14 days. | 8 |
| Part 2: PF-07059013 800 mg MD With Polymer In Part 2, participants were given multiple doses of study intervention QD for 14 days. | 8 |
| Part 2: PF-07059013 1600 mg MD With Polymer In Part 2, participants were given multiple doses of study intervention QD for 14 days. | 7 |
| Part 2: PF-07059013 3000 mg MD With Polymer In Part 2, participants were given multiple doses of study intervention QD for 14 days. | 6 |
| Part 2: PF-07059013 4000 mg MD With Polymer In Part 2, participants were given multiple doses of study intervention QD for 14 days. | 6 |
| P->Q->R->S In Part 3, participants were given a single dose of study intervention assigned under fed or fasted conditions.
P-\>Q-\>R-\>S: Suspension Fasted Polymer (Small Particle Size)-\>Tablet Fasted w/o Polymer-\>Suspension Fed Polymer (Small Particle Size)-\>Suspension Fasted Polymer (Moderate Particle Size) | 2 |
| P->Q->S->R In Part 3, participants were given a single dose of study intervention assigned under fed or fasted conditions.
P-\>Q-\>S-\>R: Suspension Fasted Polymer (Small Particle Size)-\>Tablet Fasted w/o Polymer-\>Suspension Fasted Polymer (Moderate Particle Size)-\>Suspension Fed Polymer (Small Particle Size) | 1 |
| Q->P->R->S In Part 3, participants were given a single dose of study intervention assigned under fed or fasted conditions.
Q-\>P-\>R-\>S: Tablet Fasted w/o Polymer-\>Suspension Fasted Polymer (Small Particle Size)-\>Suspension Fed Polymer (Small Particle Size)-\>Suspension Fasted Polymer (Moderate Particle Size) | 1 |
| Q->P->S->R In Part 3, participants were given a single dose of study intervention assigned under fed or fasted conditions.
Q-\>P-\>S-\>R: Tablet Fasted w/o Polymer-\>Suspension Fasted Polymer (Small Particle Size)-\>Suspension Fasted Polymer (Moderate Particle Size)-\>Suspension Fed Polymer (Small Particle Size) | 1 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Coming from a red zone (COVID) | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | No longer meets eligibility criteria | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Other | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Study terminated by sponsor | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | A->D->F->H | A->E->G->I | B->A->F->H | B->D->A->H | C->A->G->I | C->E->A->I | Part 2: Placebo MD With Polymer | Part 2: PF-07059013 800 mg MD With Polymer | Part 2: PF-07059013 1600 mg MD With Polymer | Part 2: PF-07059013 3000 mg MD With Polymer | Part 2: PF-07059013 4000 mg MD With Polymer | P->Q->R->S | P->Q->S->R | Q->P->R->S | Q->P->S->R | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 18-25 Years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 4 Participants | 4 Participants | 1 Participants | 2 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 15 Participants |
| Age, Customized <18 Years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Customized 26-35 Years | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 1 Participants | 2 Participants | 4 Participants | 3 Participants | 2 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 18 Participants |
| Age, Customized 36-45 Years | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 2 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 14 Participants |
| Age, Customized >45 Years | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 2 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 14 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 1 Participants | 3 Participants | 1 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 9 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 2 Participants | 3 Participants | 3 Participants | 2 Participants | 2 Participants | 3 Participants | 8 Participants | 7 Participants | 6 Participants | 6 Participants | 5 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 52 Participants |
| Race/Ethnicity, Customized Not reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 5 Participants | 2 Participants | 7 Participants | 7 Participants | 5 Participants | 5 Participants | 6 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 54 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 5 Participants | 4 Participants | 8 Participants | 8 Participants | 7 Participants | 6 Participants | 6 Participants | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 61 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 9 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 4 | 0 / 1 |
| other Total, other adverse events | 3 / 18 | 2 / 6 | 2 / 5 | 0 / 6 | 1 / 6 | 0 / 6 | 4 / 6 | 2 / 9 | 4 / 8 | 4 / 8 | 7 / 8 | 7 / 7 | 4 / 6 | 5 / 6 | 3 / 3 | 2 / 4 | 0 / 1 |
| serious Total, serious adverse events | 0 / 18 | 0 / 6 | 0 / 5 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 9 | 0 / 8 | 0 / 8 | 0 / 8 | 0 / 7 | 0 / 6 | 0 / 6 | 0 / 3 | 0 / 4 | 0 / 1 |
Outcome results
Primary
Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance
Clinical significance of 12-Lead ECG data was assessed by the investigator. ECG findings with abnormalities were reported. Evaluation activities as: Part 1: At Screening, 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72, 96, and 168 hours post dose. Part 2: At Screening, Day 1, 2, 4, 7, 10, 14, 15, 18, 21. Part 3: At Screening, 0, 2, 5, 8, 12, 24, 48, and 96 hours post dose.
Time frame: Part 1: from Screening to Day 8; Part 2: from Screening to Day 21; Part 3: from Screening to Day 5.
Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention were included in safety analysis set. Participants were analyzed according to the product they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 2 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 1 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 1 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 1 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 2 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 1 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 4 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 2 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 1 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 1 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 2 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 450<Value<480 | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCF interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | QTCB Interval, Aggregate (msec), 30<=Change<=60 | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Electrocardiogram (ECG) Findings of Potential Clinical Importance | PR Interval, Aggregate (msec) %Change>=25/50 | 0 Participants |
Primary
Number of Participants With Laboratory Test Findings of Potential Clinical Importance
Protocol-required safety laboratory assessments included chemistry, hematology, and urinalysis (and microscopy, if needed). Each parameter was evaluated against commonly used and widely accepted criteria. Laboratory test with abnormalities are reported. Evaluation activities as: Part 1: At Screening, Day -1, and Day 1 (at 8 hours post dose), 2, 5, 8. Part 2: At Screening, Day -1, 1, 2, 4, 7, 10, 14, 18, 21. Part 3: At Screening, Day -1, 2, 5.
Time frame: Part 1: from Screening to Day 8; Part 2: from Screening to Day 21; Part 3: from Screening to Day 5.
Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention were included in safety analysis set. Participants were analyzed according to the product they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 1 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 1 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 1 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 1 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 1 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 1 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 1 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 1 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 1 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 1 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 1 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 1 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 1 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 1 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 1 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 1 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 1 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 1 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 1 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 1 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 1 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 1 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 1 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 1 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 1 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 1 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 1 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 1 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 2 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 1 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 1 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 1 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 1 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 1 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 1 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 1 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 1 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 1 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 2 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 2 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 1 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 1 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 1 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 1 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 1 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils(10^9/L) <0.8 x LLN | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Hemoglobin >=1 | 1 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes (10^9/L) >1.5 x upper limit of normal (ULN) | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Specific Gravity (Urinalysis) <1.003 | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils (10^9/L) >1.2 x ULN | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Erythropoietin (IU/L) >1.0 x ULN | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lactic Acid (mmol/L) >1.0 x ULN | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Neutrophils/Leukocytes (%) <0.8 x LLN | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Reticulocytes/Erythrocytes (L/L) >1.5 x ULN | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Protein >=1 | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes(10^9/L) >1.2 x ULN | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Eosinophils/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Direct Bilirubin (micromol/L) >1.5 x ULN | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea Nitrogen (mmol/L) >1.3 x ULN | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Lymphocytes/Leukocytes (%) <0.8 x lower limit of normal (LLN) | 1 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Monocytes/Leukocytes (%) >1.2 x ULN | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | URINE Bilirubin >=1 | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Leukocyte Esterase (Urinalysis) >=1 | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Laboratory Test Findings of Potential Clinical Importance | Urea (mmol/L) >1.3 x ULN | 0 Participants |
Primary
Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE)
Adverse events (AEs): any untoward medical occurrence in a clinical investigation participant administered a product or medical device, without regard to causality. Treatment-emergent AEs (TEAEs): AEs which occurred for the first time during the effective duration of treatment or AEs that increased in severity during treatment. Treatment-related TEAEs were any untoward medical occurrence attributed to study intervention. Relatedness to study treatment was determined by the investigator. Duration of participation of Part 1 and Part 3, from the screening visit to the follow-up phone call, was approximately 15 weeks. Duration of participation of Part 2, from the screening visit to the follow-up phone call, was approximately 10 weeks.
Time frame: Baseline up to Follow-Up (15 weeks in Part 1 and Part 3, and 10 weeks in Part 2)
Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention were included in safety analysis set. Participants were analyzed according to the product they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 3 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 2 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 2 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 1 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 2 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 1 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 1 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 1 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 4 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 3 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 2 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 1 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 4 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 3 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 4 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 4 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 7 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 6 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 6 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 7 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 4 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 4 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 5 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 5 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 3 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 2 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 2 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 2 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | All-causality | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Treatment Emergent Treatment-Related Adverse Event(s) (Treatment-Related TEAE) | Treatment-related | 0 Participants |
Primary
Number of Participants With Vital Signs Findings of Potential Clinical Importance
Vital sign data included supine blood pressure, pulse rate, orthostatic blood pressure and oral temperature. Vital signs with abnormalities are reported. Evaluation activities as: Part 1: Supine blood pressure and pulse rate: At Screening, 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72, 96, and 168 hours post dose. Orthostatic blood pressure, respiratory rate and oral temperature: 0, 2, 8, and 24 hours post dose. Part 2: Supine blood pressure and pulse rate: At Screening, Day 1, 2, 4, 7, 10, 14, 15, 18, 21. Orthostatic blood pressure, respiratory rate and oral temperature: Day 1, 7, 14, 18. Part 3: Supine blood pressure and pulse rate: At Screening, 0, 2, 5, 8, 12, 24, 48, and 96 hours post dose. Respiratory rate and oral temperature: 0, 24 and 96 hours post dose.
Time frame: Part 1: from Screening to Day 8; Part 2: from Screening to Day 21; Part 3: from Screening to Day 5.
Population: All participants randomly assigned to study intervention and who took at least 1 dose of study intervention were included in safety analysis set. Participants were analyzed according to the product they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 1 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 1 Participants |
| Part 1: Placebo Single Dose (SD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 1: PF-07059013 100 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 1 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 1: PF-07059013 250 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 0 Participants |
| Part 1: PF-07059013 500 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 1: PF-07059013 1000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 1: PF-07059013 2000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 1: PF-07059013 3000 mg SD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 1 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 1: PF-07059013 3000 mg SD Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 1 Participants |
| Part 2: Placebo Multiple Doses (MD) With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 2: PF-07059013 800 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 2: PF-07059013 1600 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 2: PF-07059013 3000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 2: PF-07059013 4000 mg MD With Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 3: Suspension Fasted Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
| Part 3: Tablet Fasted Without Polymer | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Value <90 | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value >120 bpm | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Pulse Rate (beats/min) Value <40 bpm | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 increase | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Value <50 | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Diastolic Blood Pressure (mmHg) Change >=20 decrease | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 increase | 0 Participants |
| Part 3: Suspension Fed Polymer (Small Particle Size) | Number of Participants With Vital Signs Findings of Potential Clinical Importance | Supine Systolic Blood Pressure (mmHg) Change >=30 decrease | 0 Participants |
Secondary
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1
p20 and p50 change from baseline in Part 1 was evaluated.
Time frame: Part 1: 0 and 8 hours post dose.
Population: The analysis population referred to all participants dosed who had at least 1 of the pharmacodynamics parameters of secondary interest.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p50 at Day 1 8H | 0.50 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p20 at Day 1 8H | 0.05 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p20 at Day 1 8H | 0.10 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p50 at Day 1 8H | 0.25 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p50 at Day 1 8H | 0.20 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p20 at Day 1 8H | 0.00 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p20 at Day 1 8H | -0.05 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p50 at Day 1 8H | 0.15 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p20 at Day 1 8H | -0.05 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p50 at Day 1 8H | 0.50 mmHg |
| Part 1: PF-07059013 2000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p50 at Day 1 8H | -0.25 mmHg |
| Part 1: PF-07059013 2000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p20 at Day 1 8H | -0.40 mmHg |
| Part 1: PF-07059013 3000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p20 at Day 1 8H | -1.00 mmHg |
| Part 1: PF-07059013 3000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p50 at Day 1 8H | -0.45 mmHg |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p20 at Day 1 8H | -0.70 mmHg |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p50 at Day 1 8H | -0.30 mmHg |
| Part 1: PF-07059013 3000 mg SD Without Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p50 at Day 1 8H | -0.45 mmHg |
| Part 1: PF-07059013 3000 mg SD Without Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 1 | p20 at Day 1 8H | -1.30 mmHg |
Secondary
p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2
p20 and p50 change from baseline in Part 2 was evaluated.
Time frame: Part 2: 0 and 8 hours post dose on Day 1, 7 and 14, and on Day 2, 15, 18.
Population: The analysis population referred to all participants dosed who had at least 1 of the pharmacodynamics parameters of secondary interest.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 7 0H | 0.70 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 24H | -0.65 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 1 2H | 0.10 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 0H | 0.60 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 0H | 0.35 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 7 2H | 0.80 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 2 | 0.30 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 2H | 0.40 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 24H | -0.85 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 7 0H | 0.60 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 1 2H | 0.30 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 96H | -0.70 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 2H | 0.75 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 2 | 0.85 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 96H | -0.10 mmHg |
| Part 1: Placebo Single Dose (SD) With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 7 2H | 0.30 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 2 | 1.00 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 0H | 0.70 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 7 0H | -1.30 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 7 2H | -1.30 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 7 0H | -0.65 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 1 2H | -0.30 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 7 2H | -1.20 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 24H | 1.30 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 0H | 0.40 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 2H | -0.05 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 24H | 0.50 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 2 | 0.55 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 2H | 1.05 mmHg |
| Part 1: PF-07059013 100 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 1 2H | 0.00 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 7 2H | -0.70 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 1 2H | -0.90 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 24H | 0.20 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 0H | 1.40 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 7 0H | 0.70 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 24H | 1.10 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 96H | 1.70 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 2 | -1.00 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 7 0H | 0.00 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 7 2H | 0.70 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 2 | -0.40 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 96H | 2.70 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 1 2H | -0.40 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 2H | -0.20 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 0H | 0.00 mmHg |
| Part 1: PF-07059013 250 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 2H | 1.00 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 7 2H | -3.60 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 1 2H | -1.25 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 2 | -0.45 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 7 0H | -1.60 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 0H | -2.70 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 2H | -5.20 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 24H | -1.40 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 96H | 0.15 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 1 2H | -0.35 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 2 | 0.25 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 7 0H | -0.30 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 7 2H | -2.20 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 0H | -2.00 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 2H | -3.50 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 24H | -0.50 mmHg |
| Part 1: PF-07059013 500 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 96H | 0.15 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 2 | -2.10 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 0H | -0.70 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 96H | 1.40 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 24H | -1.35 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 2H | -8.05 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 1 2H | -2.00 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 2H | -2.80 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 14 0H | -2.20 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 7 2H | -3.05 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p20 at Day 7 0H | -1.05 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 96H | 2.90 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 14 24H | 0.45 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 7 2H | -0.60 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 7 0H | 0.10 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 2 | -1.45 mmHg |
| Part 1: PF-07059013 1000 mg SD With Polymer | p20 and p50 (Partial Pressure of Oxygen at Which Hemoglobin is 20% or 50% Saturated With Oxygen) Change From Baseline in Part 2 | p50 at Day 1 2H | -0.95 mmHg |
Secondary
PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1
PF-07059013 Blood and Plasma AUClast of Part 1 was evaluated. For Part 1, in period 1, participants were given PF-07059013 100 mg SD and PF-07059013 250 mg SD, all with polymer; in period 2, participants were given PF-07059013 500 mg SD and PF-07059013 1000 mg SD, all with polymer; in period 3, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all with polymer; in period 4, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all without polymer.
Time frame: 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72 (period 2-4 only), 96 (period 2-4 only), and 168 hours post dose of each period.
Population: The analysis population referred to all participants dosed who had at least 1 of the PK parameters of secondary interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Blood | 14870 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 49 |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Plasma | 520.5 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 45 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Blood | 73300 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 45 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Plasma | 1699 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 28 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Blood | 211400 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 65 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Plasma | 3224 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 37 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Blood | 639800 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 47 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Plasma | 7505 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 24 |
| Part 1: PF-07059013 1000 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Blood | 1582000 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 68 |
| Part 1: PF-07059013 1000 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Plasma | 12310 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 16 |
| Part 1: PF-07059013 2000 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Blood | 4091000 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 34 |
| Part 1: PF-07059013 2000 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Plasma | 20520 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 26 |
| Part 1: PF-07059013 3000 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Plasma | 12640 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 30 |
| Part 1: PF-07059013 3000 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Blood | 1692000 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 69 |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Blood | 3562000 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 77 |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Part 1 | Plasma | 19130 nanogram*hour per milliliter (ng*hr/mL) | Geometric Coefficient of Variation 56 |
Secondary
PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2
PF-07059013 Blood and Plasma AUCtau (the Dosing Interval, Where Tau = 24 Hours for QD Dosing) for Part 2 was evaluated.
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12 hours post dose on Day 1, 7, and 14.
Population: The analysis population referred to all participants dosed who had at least 1 of the PK parameters of secondary interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 1 in Blood | 594600 ng*hr/mL | Geometric Coefficient of Variation 22 |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 1 in Plasma | 5024 ng*hr/mL | Geometric Coefficient of Variation 15 |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 7 in Blood | 1184000 ng*hr/mL | Geometric Coefficient of Variation 31 |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 7 in Plasma | 7608 ng*hr/mL | Geometric Coefficient of Variation 25 |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 14 in Blood | 981000 ng*hr/mL | Geometric Coefficient of Variation 29 |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 14 in Plasma | 7568 ng*hr/mL | Geometric Coefficient of Variation 26 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 14 in Plasma | 14330 ng*hr/mL | Geometric Coefficient of Variation 22 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 7 in Plasma | 13680 ng*hr/mL | Geometric Coefficient of Variation 38 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 1 in Blood | 1942000 ng*hr/mL | Geometric Coefficient of Variation 37 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 7 in Blood | 4108000 ng*hr/mL | Geometric Coefficient of Variation 42 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 1 in Plasma | 8358 ng*hr/mL | Geometric Coefficient of Variation 24 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 14 in Blood | 4165000 ng*hr/mL | Geometric Coefficient of Variation 29 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 1 in Plasma | 16210 ng*hr/mL | Geometric Coefficient of Variation 18 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 7 in Blood | 8027000 ng*hr/mL | Geometric Coefficient of Variation 38 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 7 in Plasma | 24280 ng*hr/mL | Geometric Coefficient of Variation 21 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 14 in Plasma | 26500 ng*hr/mL | Geometric Coefficient of Variation 20 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 14 in Blood | 7730000 ng*hr/mL | Geometric Coefficient of Variation 21 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 1 in Blood | 4408000 ng*hr/mL | Geometric Coefficient of Variation 33 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 14 in Blood | 9944000 ng*hr/mL | Geometric Coefficient of Variation 22 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 14 in Plasma | 31640 ng*hr/mL | Geometric Coefficient of Variation 25 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 1 in Plasma | 18670 ng*hr/mL | Geometric Coefficient of Variation 37 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 7 in Plasma | 29960 ng*hr/mL | Geometric Coefficient of Variation 30 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 1 in Blood | 4884000 ng*hr/mL | Geometric Coefficient of Variation 34 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Area Under the Concentration-Time Profile From Time 0 to Time Tau (AUCtau) of Part 2 | Day 7 in Blood | 8666000 ng*hr/mL | Geometric Coefficient of Variation 18 |
Secondary
PF-07059013 Blood and Plasma Cmax of Part 2
PF-07059013 Blood and Plasma Cmax of Part 2 was evaluated.
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12 hours post dose on Day 1, 7, and 14.
Population: The analysis population referred to all participants dosed who had at least 1 of the PK parameters of secondary interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 1 in Blood | 57230 ng/mL | Geometric Coefficient of Variation 20 |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 1 in Plasma | 427.1 ng/mL | Geometric Coefficient of Variation 23 |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 7 in Blood | 86020 ng/mL | Geometric Coefficient of Variation 18 |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 7 in Plasma | 513.6 ng/mL | Geometric Coefficient of Variation 22 |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 14 in Blood | 79690 ng/mL | Geometric Coefficient of Variation 21 |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 14 in Plasma | 569.4 ng/mL | Geometric Coefficient of Variation 44 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 14 in Plasma | 868.2 ng/mL | Geometric Coefficient of Variation 33 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 7 in Plasma | 913.9 ng/mL | Geometric Coefficient of Variation 40 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 1 in Blood | 149500 ng/mL | Geometric Coefficient of Variation 29 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 7 in Blood | 275700 ng/mL | Geometric Coefficient of Variation 28 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 1 in Plasma | 597.2 ng/mL | Geometric Coefficient of Variation 24 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 14 in Blood | 275800 ng/mL | Geometric Coefficient of Variation 28 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 1 in Plasma | 1071 ng/mL | Geometric Coefficient of Variation 21 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 7 in Blood | 521600 ng/mL | Geometric Coefficient of Variation 38 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 7 in Plasma | 1496 ng/mL | Geometric Coefficient of Variation 23 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 14 in Plasma | 1791 ng/mL | Geometric Coefficient of Variation 33 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 14 in Blood | 520000 ng/mL | Geometric Coefficient of Variation 20 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 1 in Blood | 332100 ng/mL | Geometric Coefficient of Variation 27 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 14 in Blood | 623700 ng/mL | Geometric Coefficient of Variation 22 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 14 in Plasma | 1958 ng/mL | Geometric Coefficient of Variation 18 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 1 in Plasma | 1339 ng/mL | Geometric Coefficient of Variation 29 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 7 in Plasma | 2157 ng/mL | Geometric Coefficient of Variation 32 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 1 in Blood | 337500 ng/mL | Geometric Coefficient of Variation 37 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Cmax of Part 2 | Day 7 in Blood | 576900 ng/mL | Geometric Coefficient of Variation 17 |
Secondary
PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1
PF-07059013 Blood and Plasma Cmax for Part 1 was evaluated. For Part 1, in period 1, participants were given PF-07059013 100 mg SD and PF-07059013 250 mg SD, all with polymer; in period 2, participants were given PF-07059013 500 mg SD and PF-07059013 1000 mg SD, all with polymer; in period 3, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all with polymer; in period 4, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all without polymer.
Time frame: 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72 (period 2-4 only), 96 (period 2-4 only), and 168 hours post dose of each period.
Population: The analysis population referred to all participants dosed who had at least 1 of the pharmacokinetics (PK) parameters of secondary interest.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Blood | 4773 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 36 |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Plasma | 88.51 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 19 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Blood | 11990 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 43 |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Plasma | 160.2 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 31 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Blood | 25140 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 51 |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Plasma | 250.1 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 32 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Blood | 52830 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 38 |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Plasma | 509.2 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 22 |
| Part 1: PF-07059013 1000 mg SD With Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Blood | 104200 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 63 |
| Part 1: PF-07059013 1000 mg SD With Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Plasma | 555.3 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 30 |
| Part 1: PF-07059013 2000 mg SD With Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Blood | 231700 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 31 |
| Part 1: PF-07059013 2000 mg SD With Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Plasma | 917.7 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 38 |
| Part 1: PF-07059013 3000 mg SD With Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Plasma | 496.1 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 32 |
| Part 1: PF-07059013 3000 mg SD With Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Blood | 107000 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 54 |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Blood | 191700 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 55 |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | PF-07059013 Blood and Plasma Maximum Observed Concentration (Cmax) of Part 1 | Plasma | 796.5 nanogram per milliliter (ng/mL) | Geometric Coefficient of Variation 39 |
Secondary
PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1
PF-07059013 Blood and Plasma Tmax for Part 1 was evaluated. For Part 1, in period 1, participants were given PF-07059013 100 mg SD and PF-07059013 250 mg SD, all with polymer; in period 2, participants were given PF-07059013 500 mg SD and PF-07059013 1000 mg SD, all with polymer; in period 3, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all with polymer; in period 4, participants were given PF-07059013 2000 mg SD and PF-07059013 3000 mg SD, all without polymer.
Time frame: 0, 0.5, 1, 2, 5, 8, 12, 24, 36, 48, 72 (period 2-4 only), 96 (period 2-4 only), and 168 hours post dose of each period.
Population: The analysis population referred to all participants dosed who had at least 1 of the PK parameters of secondary interest.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Blood | 1.00 hour |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Plasma | 1.00 hour |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Blood | 1.00 hour |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Plasma | 1.00 hour |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Blood | 1.00 hour |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Plasma | 2.00 hour |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Blood | 2.00 hour |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Plasma | 2.00 hour |
| Part 1: PF-07059013 1000 mg SD With Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Blood | 2.00 hour |
| Part 1: PF-07059013 1000 mg SD With Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Plasma | 2.00 hour |
| Part 1: PF-07059013 2000 mg SD With Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Blood | 5.00 hour |
| Part 1: PF-07059013 2000 mg SD With Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Plasma | 3.57 hour |
| Part 1: PF-07059013 3000 mg SD With Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Plasma | 2.03 hour |
| Part 1: PF-07059013 3000 mg SD With Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Blood | 2.03 hour |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Blood | 2.00 hour |
| Part 1: PF- 07059013 2000 mg SD Without Polymer | PF-07059013 Blood and Plasma Time for Cmax (Tmax) of Part 1 | Plasma | 2.01 hour |
Secondary
PF-07059013 Blood and Plasma Tmax of Part 2
PF-07059013 Blood and Plasma Tmax of Part 2 was evaluated.
Time frame: 0, 0.5, 1, 2, 4, 6, 8, 12 hours post dose on Day 1, 7, and 14.
Population: The analysis population referred to all participants dosed who had at least 1 of the PK parameters of secondary interest.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 1 in Blood | 3.01 hour |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 1 in Plasma | 3.02 hour |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 7 in Blood | 2.03 hour |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 7 in Plasma | 4.00 hour |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 14 in Blood | 2.02 hour |
| Part 1: Placebo Single Dose (SD) With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 14 in Plasma | 2.01 hour |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 14 in Plasma | 4.02 hour |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 7 in Plasma | 4.07 hour |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 1 in Blood | 4.00 hour |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 7 in Blood | 4.03 hour |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 1 in Plasma | 4.00 hour |
| Part 1: PF-07059013 100 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 14 in Blood | 4.00 hour |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 1 in Plasma | 4.05 hour |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 7 in Blood | 4.02 hour |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 7 in Plasma | 4.05 hour |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 14 in Plasma | 4.01 hour |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 14 in Blood | 4.01 hour |
| Part 1: PF-07059013 250 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 1 in Blood | 4.07 hour |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 14 in Blood | 4.03 hour |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 14 in Plasma | 4.03 hour |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 1 in Plasma | 6.00 hour |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 7 in Plasma | 5.01 hour |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 1 in Blood | 4.02 hour |
| Part 1: PF-07059013 500 mg SD With Polymer | PF-07059013 Blood and Plasma Tmax of Part 2 | Day 7 in Blood | 4.03 hour |