Healthy
Conditions
Keywords
PF-07104091, Food-effect, Relative Bioavailability, Pharmacokinetics, Cyclin-Dependent Kinase 2 (CDK2) inhibitor
Brief summary
This is a single dose crossover pharmacokinetic (pharmacokinetics helps in understanding how the drug is changed and eliminated from the body after a participant takes it) study in healthy participants. The study consists of 5 treatments, and each participant will be randomized to receive 4 of the treatments in separate periods in a specific sequence. Each treatment consists of a single dose of PF-07104091 and the treatments differ by tablet formulation and/or whether the dose is to be given under fasted or fed conditions. Plasma pharmacokinetics of PF-07104091 will be assessed following each dose to determine the effect of tablet formulation and fed condition on the relative bioavailability of PF-07104091.
Interventions
DRUGSingle dose of PF-07104091 as Tablet Formulation A (Treatment A)
A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions.
DRUGSingle dose of PF-07104091 as Tablet Formulation B (Treatment B)
A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions.
DRUGSingle dose of PF-07104091 as Tablet Formulation C (Treatment C)
A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions.
DRUGSingle dose of PF-07104091 as Tablet Formulation D (Treatment D)
A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions.
DRUGSingle dose of PF-07104091 as Tablet Formulation C (Treatment E)
A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Masking description
Open-label Study
Intervention model description
Randomized, open-label, 4-period, 5-treatment, 6-sequence, crossover study.
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Male participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs, and standard 12 lead ECGs. * Body-Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight of \>50 kg (110 lb). * Written evidence of a personally signed and dated informed consent document (ICD) indicating that the participant has been informed of all pertinent aspects of the study. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
Exclusion criteria
* 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). * Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy). * History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAB) or hepatitis C antibody (HCVAb). Hepatitis B vaccination is allowed. * Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions or situations related to COVID-19 pandemic (eg, contact with positive case, residence, or travel to an area with high incidence) that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study. * 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. * A positive urine drug test. * History of sensitivity to heparin or heparin induced thrombocytopenia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C | Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose | AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. |
| Maximum Observed Plasma Concentration (Cmax) of PF-07104091 for Treatment A, B and C | Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose | Cmax was maximum observed concentration. Cmax was observed directly from data. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) | An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, other important medical events. TEAEs were defined as events that occurred after start of treatment. |
| Number of Participants With Laboratory Test Abnormalities | From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) | Clinical hematology parameters included: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes; chemistry parameters included: blood urea nitrogen and creatinine, cystatin C and estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, urinalysis parameters included: local dipstick: potential of hydrogen (pH), glucose, protein, blood, ketones, nitrites, leukocyte esterase. Number of participants with abnormal findings are presented in this outcome measure. |
| AUCinf of PF-07104091 for Treatment C, D and E | Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose | AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve. |
| Number of Participants With Clinically Meaningful Findings in Vital Signs | From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) | Vital signs were measured with the participant's arm supported at the level of the heart after approximately 5 minutes of rest. Vital signs parameters included: diastolic and systolic blood pressure, respiratory rate, pulse rate, and temperature. Number of participants with clinically meaningful findings in any vital sign parameter were reported. Clinically meaningful findings were based on the investigator's judgment. |
| Number of Participants With Clinically Meaningful Findings in Physical Examination Assessments | From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) | A complete physical examination included at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant-reported symptoms. Clinically significant findings were defined according to investigator's assessment. |
| Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments | From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) | A 12-lead ECG was performed. Clinically meaningful findings in ECG assessments were based on the investigator's judgment. |
| Cmax of PF-07104091 for Treatment C, D and E | Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose | Cmax was maximum observed concentration. Cmax was observed directly from data. |
Countries
United States
Participant flow
Pre-assignment details
A total of 30 participants were randomly assigned and received the study treatment.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Sequence ABCD+BCAD+CABD All participants who received Treatment A: PF-07104091 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation A, under fasting condition, treatment B: 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation B under fasting condition, treatment C: 300 mg (4\*75 mg) tablet Formulation C under fasting condition, treatment D: 300 mg (4\*75 mg) tablet Formulation D under fasting condition, in either Period 1, 2, 3, and 4 based on the treatment sequence were included. | 15 |
| Treatment Sequence ABCE+BCAE+CABE All participants who received Treatment A: PF-07104091 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation A, under fasting condition, treatment B: 300 mg (2\*125 mg and 2\*25 mg) tablet Formulation B, under fasting condition, treatment C: 300 mg (4\*75 mg) tablet Formulation C under fasting condition, treatment E: 300 mg (4\*75 mg) tablet Formulation C under fed condition in either Period 1, 2, 3, and 4 based on the treatment sequence were included. | 15 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Treatment Period 1 (Day 1) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Treatment Sequence ABCE+BCAE+CABE | Total | Treatment Sequence ABCD+BCAD+CABD |
|---|---|---|---|
| Age, Continuous | 40.3 Years STANDARD_DEVIATION 13.06 | 41.1 Years STANDARD_DEVIATION 12.85 | 41.9 Years STANDARD_DEVIATION 13.04 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 7 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 23 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 14 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 7 Participants | 13 Participants | 6 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 15 Participants | 30 Participants | 15 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 |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 30 | 0 / 29 | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 21 / 29 | 18 / 30 | 17 / 29 | 7 / 15 | 2 / 14 |
| serious Total, serious adverse events | 0 / 29 | 0 / 30 | 0 / 29 | 0 / 15 | 0 / 14 |
Outcome results
Primary
Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C
AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve.
Time frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Population: Pharmacokinetic (PK) Parameter set included all participants randomized and treated who had at least 1 of the PF-07104091 PK parameters of primary interest in at least 1 treatment period. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: PF-07104091 Tablet Formulation A (Fasted) | Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C | 10920 Nanograms*hour per milliliter | Geometric Coefficient of Variation 34 |
| Treatment B: PF-07104091 Tablet Formulation B (Fasted) | Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C | 10720 Nanograms*hour per milliliter | Geometric Coefficient of Variation 28 |
| Treatment C: PF-07104091 Tablet Formulation C (Fasted) | Area Under the Plasma-Concentration Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of PF-07104091 for Treatment A, B, and C | 11200 Nanograms*hour per milliliter | Geometric Coefficient of Variation 32 |
90% CI: [94, 103.91]
90% CI: [93.88, 102.35]
90% CI: [91.79, 105.73]
Primary
Maximum Observed Plasma Concentration (Cmax) of PF-07104091 for Treatment A, B and C
Cmax was maximum observed concentration. Cmax was observed directly from data.
Time frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Population: PK Parameter set included all participants randomized and treated who had at least 1 of the PF-07104091 PK parameters of primary interest in at least 1 treatment period. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: PF-07104091 Tablet Formulation A (Fasted) | Maximum Observed Plasma Concentration (Cmax) of PF-07104091 for Treatment A, B and C | 1531 Nanograms per milliliter | Geometric Coefficient of Variation 31 |
| Treatment B: PF-07104091 Tablet Formulation B (Fasted) | Maximum Observed Plasma Concentration (Cmax) of PF-07104091 for Treatment A, B and C | 1490 Nanograms per milliliter | Geometric Coefficient of Variation 28 |
| Treatment C: PF-07104091 Tablet Formulation C (Fasted) | Maximum Observed Plasma Concentration (Cmax) of PF-07104091 for Treatment A, B and C | 1415 Nanograms per milliliter | Geometric Coefficient of Variation 34 |
90% CI: [89.86, 106.9]
90% CI: [87.48, 106.12]
90% CI: [85.65, 102]
Secondary
AUCinf of PF-07104091 for Treatment C, D and E
AUCinf was calculated as AUClast + (Clast/kel) where Clast was the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel was the terminal phase rate constant calculated by a linear regression of the log linear concentration-time curve.
Time frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Population: PK Parameter set included all participants randomized and treated who had at least 1 of the PF-07104091 PK parameters of primary interest in at least 1 treatment period. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: PF-07104091 Tablet Formulation A (Fasted) | AUCinf of PF-07104091 for Treatment C, D and E | 11200 Nanograms*hour per milliliter | Geometric Coefficient of Variation 32 |
| Treatment B: PF-07104091 Tablet Formulation B (Fasted) | AUCinf of PF-07104091 for Treatment C, D and E | 12850 Nanograms*hour per milliliter | Geometric Coefficient of Variation 32 |
| Treatment C: PF-07104091 Tablet Formulation C (Fasted) | AUCinf of PF-07104091 for Treatment C, D and E | 10500 Nanograms*hour per milliliter | Geometric Coefficient of Variation 24 |
90% CI: [99.55, 124.93]
90% CI: [90.68, 106.73]
Secondary
Cmax of PF-07104091 for Treatment C, D and E
Cmax was maximum observed concentration. Cmax was observed directly from data.
Time frame: Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose
Population: PK Parameter set included all participants randomized and treated who had at least 1 of the PF-07104091 PK parameters of primary interest in at least 1 treatment period. Here, Overall Number of Participants Analyzed signifies participants evaluable for this outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A: PF-07104091 Tablet Formulation A (Fasted) | Cmax of PF-07104091 for Treatment C, D and E | 1415 Nanograms per milliliter | Geometric Coefficient of Variation 34 |
| Treatment B: PF-07104091 Tablet Formulation B (Fasted) | Cmax of PF-07104091 for Treatment C, D and E | 1498 Nanograms per milliliter | Geometric Coefficient of Variation 36 |
| Treatment C: PF-07104091 Tablet Formulation C (Fasted) | Cmax of PF-07104091 for Treatment C, D and E | 1193 Nanograms per milliliter | Geometric Coefficient of Variation 36 |
90% CI: [96.46, 128.93]
90% CI: [75.06, 88.26]
Secondary
Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments
A 12-lead ECG was performed. Clinically meaningful findings in ECG assessments were based on the investigator's judgment.
Time frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment A: PF-07104091 Tablet Formulation A (Fasted) | Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments | 0 Participants |
| Treatment B: PF-07104091 Tablet Formulation B (Fasted) | Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments | 0 Participants |
| Treatment C: PF-07104091 Tablet Formulation C (Fasted) | Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments | 0 Participants |
| Treatment D: PF-07104091 Tablet Formulation D (Fasted) | Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments | 0 Participants |
| Treatment E: PF-07104091 Tablet Formulation C (Fed) | Number of Participants With Clinically Meaningful Findings in Electrocardiogram (ECG) Assessments | 0 Participants |
Secondary
Number of Participants With Clinically Meaningful Findings in Physical Examination Assessments
A complete physical examination included at a minimum, head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes, and gastrointestinal, musculoskeletal, and neurological systems. A brief physical examination included at a minimum, assessments of general appearance, the respiratory and cardiovascular systems, and participant-reported symptoms. Clinically significant findings were defined according to investigator's assessment.
Time frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment A: PF-07104091 Tablet Formulation A (Fasted) | Number of Participants With Clinically Meaningful Findings in Physical Examination Assessments | 0 Participants |
| Treatment B: PF-07104091 Tablet Formulation B (Fasted) | Number of Participants With Clinically Meaningful Findings in Physical Examination Assessments | 0 Participants |
| Treatment C: PF-07104091 Tablet Formulation C (Fasted) | Number of Participants With Clinically Meaningful Findings in Physical Examination Assessments | 0 Participants |
| Treatment D: PF-07104091 Tablet Formulation D (Fasted) | Number of Participants With Clinically Meaningful Findings in Physical Examination Assessments | 0 Participants |
| Treatment E: PF-07104091 Tablet Formulation C (Fed) | Number of Participants With Clinically Meaningful Findings in Physical Examination Assessments | 0 Participants |
Secondary
Number of Participants With Clinically Meaningful Findings in Vital Signs
Vital signs were measured with the participant's arm supported at the level of the heart after approximately 5 minutes of rest. Vital signs parameters included: diastolic and systolic blood pressure, respiratory rate, pulse rate, and temperature. Number of participants with clinically meaningful findings in any vital sign parameter were reported. Clinically meaningful findings were based on the investigator's judgment.
Time frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment A: PF-07104091 Tablet Formulation A (Fasted) | Number of Participants With Clinically Meaningful Findings in Vital Signs | 0 Participants |
| Treatment B: PF-07104091 Tablet Formulation B (Fasted) | Number of Participants With Clinically Meaningful Findings in Vital Signs | 0 Participants |
| Treatment C: PF-07104091 Tablet Formulation C (Fasted) | Number of Participants With Clinically Meaningful Findings in Vital Signs | 0 Participants |
| Treatment D: PF-07104091 Tablet Formulation D (Fasted) | Number of Participants With Clinically Meaningful Findings in Vital Signs | 0 Participants |
| Treatment E: PF-07104091 Tablet Formulation C (Fed) | Number of Participants With Clinically Meaningful Findings in Vital Signs | 0 Participants |
Secondary
Number of Participants With Laboratory Test Abnormalities
Clinical hematology parameters included: hemoglobin, hematocrit, red blood cell count, platelet count, white blood cell count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes; chemistry parameters included: blood urea nitrogen and creatinine, cystatin C and estimated glomerular filtration rate, glucose (fasting), calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase, alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein, urinalysis parameters included: local dipstick: potential of hydrogen (pH), glucose, protein, blood, ketones, nitrites, leukocyte esterase. Number of participants with abnormal findings are presented in this outcome measure.
Time frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment A: PF-07104091 Tablet Formulation A (Fasted) | Number of Participants With Laboratory Test Abnormalities | 0 Participants |
| Treatment B: PF-07104091 Tablet Formulation B (Fasted) | Number of Participants With Laboratory Test Abnormalities | 0 Participants |
| Treatment C: PF-07104091 Tablet Formulation C (Fasted) | Number of Participants With Laboratory Test Abnormalities | 1 Participants |
| Treatment D: PF-07104091 Tablet Formulation D (Fasted) | Number of Participants With Laboratory Test Abnormalities | 3 Participants |
| Treatment E: PF-07104091 Tablet Formulation C (Fed) | Number of Participants With Laboratory Test Abnormalities | 1 Participants |
Secondary
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
An adverse event (AE) was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A serious adverse event (SAE) was defined as any untoward medical occurrence that, at any dose, met one or more of the following criteria: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a suspected transmission via a Pfizer product of an infectious agent, pathogenic or non-pathogenic, other important medical events. TEAEs were defined as events that occurred after start of treatment.
Time frame: From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Population: Safety analysis set included all participants randomly assigned to study intervention and who received at least 1 dose of study intervention. Participants were analyzed according to the study intervention they actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Treatment A: PF-07104091 Tablet Formulation A (Fasted) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 21 Participants |
| Treatment A: PF-07104091 Tablet Formulation A (Fasted) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Serious TEAEs | 0 Participants |
| Treatment B: PF-07104091 Tablet Formulation B (Fasted) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 19 Participants |
| Treatment B: PF-07104091 Tablet Formulation B (Fasted) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Serious TEAEs | 0 Participants |
| Treatment C: PF-07104091 Tablet Formulation C (Fasted) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 17 Participants |
| Treatment C: PF-07104091 Tablet Formulation C (Fasted) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Serious TEAEs | 0 Participants |
| Treatment D: PF-07104091 Tablet Formulation D (Fasted) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Serious TEAEs | 0 Participants |
| Treatment D: PF-07104091 Tablet Formulation D (Fasted) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 7 Participants |
| Treatment E: PF-07104091 Tablet Formulation C (Fed) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | TEAEs | 2 Participants |
| Treatment E: PF-07104091 Tablet Formulation C (Fed) | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs | Serious TEAEs | 0 Participants |