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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-07104091 Sequence 1 | Experimental | Participants randomized to Sequence 1 will receive Treatments A, B, C, and D in Periods 1 through 4, respectively in the form of tablets by mouth. |
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| PF-07104091 Sequence 2 | Experimental | Participants randomized to Sequence 2 will receive Treatments B, C, A, and D in Periods 1 through 4, respectively in the form of tablets by mouth. |
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| PF-07104091 Sequence 3 | Experimental | Participants randomized to Sequence 3 will receive Treatments C, A, B, and D in Periods 1 through 4, respectively in the form of tablets by mouth. |
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| PF-07104091 Sequence 4 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dose of PF-07104091 as Tablet Formulation A (Treatment A) | Drug | A single dose of PF-07104091 as Tablet Formulation A administered under fasting conditions. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose |
| 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. | Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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A total of 30 participants were randomly assigned and received the study treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence ABCD | Participants received a single 300 milligrams (mg) dose (2*125 mg and 2*25 mg) of PF-07104091 tablet Formulation A under fasting conditions (Treatment A) on Day 1 of period 1 followed by 300 mg (2*125 mg and 2*25 mg) tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 2 followed by 300 mg (4*75 mg) tablet Formulation C under fasting condition (Treatment C) on Day 1 of period 3 followed by 300 mg (4*75 mg) tablet Formulation D under fasting condition (Treatment D) on Day 1 of period 4. There was a washout period of 5 days between each treatment period. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 (Day 1) |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 21, 2022 | Oct 9, 2023 |
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Randomized, open-label, 4-period, 5-treatment, 6-sequence, crossover study.
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Open-label Study
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Participants randomized to Sequence 4 will receive Treatments A, B, C, and E in Periods 1 through 4, respectively in the form of tablets by mouth. |
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| PF-07104091 Sequence 5 | Experimental | Participants randomized to Sequence 5 will receive Treatments B, C, A, and E in Periods 1 through 4, respectively in the form of tablets by mouth. |
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| PF-07104091 Sequence 6 | Experimental | Participants randomized to Sequence 6 will receive Treatments C, A, B, and E in Periods 1 through 4, respectively in the form of tablets by mouth. |
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| Single dose of PF-07104091 as Tablet Formulation B (Treatment B) | Drug | A single dose of PF-07104091 as Tablet Formulation B administered under fasting conditions. |
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| Single dose of PF-07104091 as Tablet Formulation C (Treatment C) | Drug | A single dose of PF-07104091 as Tablet Formulation C administered under fasting conditions. |
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| Single dose of PF-07104091 as Tablet Formulation D (Treatment D) | Drug | A single dose of PF-07104091 as Tablet Formulation D administered under fasting conditions. |
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| Single dose of PF-07104091 as Tablet Formulation C (Treatment E) | Drug | A single dose of PF-07104091 as Tablet Formulation C administered under fed conditions. |
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| Cmax of PF-07104091 for Treatment C, D and E | Cmax was maximum observed concentration. Cmax was observed directly from data. | Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose |
| 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. | From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) |
| 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. | From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) |
| 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. | From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) |
| 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. | From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) |
| 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. | From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) |
| FG001 | Treatment Sequence BCAD | Participants received a single 300 mg (2*125 mg and 2*25 mg) PF-07104091 tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 1 followed by 300 mg (4*75 mg) tablet Formulation C under fasted condition (Treatment C) on Day 1 of treatment period 2 followed by 300 mg (2*125 mg and 2*25 mg) tablet Formulation A under fasting condition (Treatment A) on Day 1 of period 3 followed by 300 mg (4*75 mg) tablet Formulation D under fasted condition (Treatment D) on Day 1 of period 4. There was a washout period of 5 days between each treatment period. |
| FG002 | Treatment Sequence CABD | Participants received a single 300 mg (4*75 mg) PF-07104091 tablet Formulation C under fasting condition (Treatment C) on Day 1 of period 1 followed by 300 mg (2*125 mg and 2*25 mg) tablet Formulation A under fasting condition (Treatment A) on Day 1 of period 2 followed by 300 mg (2*125 mg and 2*25 mg) tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 3 followed by 300 mg (4*75 mg) tablet Formulation D under fasting condition (Treatment D) on Day 1 of period 4. There was a washout period of 5 days between each treatment period. |
| FG003 | Treatment Sequence ABCE | Participants received a single 300 mg (2*125 mg and 2*25 mg) PF-07104091 tablet Formulation A under fasting condition (Treatment A) on Day 1 of period 1 followed by 300 mg (2*125 mg and 2*25 mg) tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 2 followed by 300 mg (4*75 mg) tablet Formulation C under fasting condition (Treatment C) on Day 1 of period 3 followed by 300 mg (4*75 mg) tablet Formulation C under fed condition (Treatment E) on Day 1 of period 4. There was a washout period of 5 days between each treatment period. |
| FG004 | Treatment Sequence BCAE | Participants received a single 300 mg (2*125 mg and 2*25 mg) PF-07104091 tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 1 followed by 300 mg (4*75 mg) tablet Formulation C under fasting condition (Treatment C) on Day 1 of period 2 followed by 300 mg (2*125 mg and 2*25 mg) tablet Formulation A under fasting condition (Treatment A) on Day 1 of period 3 followed by 300 mg (4*75 mg) tablet Formulation C under fed condition (Treatment E) on Day 1 of period 4. There was a washout period of 5 days between each treatment period. |
| FG005 | Treatment Sequence CABE | Participants received a single 300 mg (4*75 mg) PF-07104091 tablet Formulation C under fasting condition (Treatment C) on Day 1 of period 1 followed by 300 mg (2*125 mg and 2*25 mg) tablet Formulation A under fasting condition (Treatment A) on Day 1 of period 2 followed by 300 mg (2*125 mg and 2*25 mg) tablet Formulation B under fasting condition (Treatment B) on Day 1 of period 3 followed by 300 mg (4*75 mg) tablet Formulation C under fed condition (Treatment E) on Day 1 of period 4. There was a washout period of 5 days between each treatment period. |
| COMPLETED |
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| NOT COMPLETED |
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| Washout Period 1 (5 Days) |
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| Treatment Period 2 (Day 1) |
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| Washout Period 2 (5 Days) |
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| Treatment Period 3 (Day 1) |
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| Washout Period 3 (5 Days) |
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| Treatment Period 4 (Day 1) |
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All enrolled participants were analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms*hour per milliliter | Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose |
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| 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms*hour per milliliter | Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose |
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| Secondary | Cmax of PF-07104091 for Treatment C, D and E | Cmax was maximum observed concentration. Cmax was observed directly from data. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | Nanograms per milliliter | Predose, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, and 48 hours post-dose |
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| 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. | 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. | Posted | Count of Participants | Participants | From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) |
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| 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. | 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. | Posted | Count of Participants | Participants | From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) |
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| 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. | 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. | Posted | Count of Participants | Participants | From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) |
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| 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. | 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. | Posted | Count of Participants | Participants | From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) |
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| 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. | 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. | Posted | Count of Participants | Participants | From start of study treatment until 35 days after last dose of study treatment (Up to Day 54) |
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From start of study treatment until 35 days after last dose of study treatment (Up to Day 54)
Analysis was performed on safety analysis set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A: PF-07104091 Tablet Formulation A (Fasted) | Participants received a single 300 mg dose (2*125 mg and 2*25 mg) of PF-07104091 tablet Formulation A, under fasting conditions. | 0 | 29 | 0 | 29 | 21 | 29 |
| EG001 | Treatment B: PF-07104091 Tablet Formulation B (Fasted) | Participants received a single 300 mg dose (2*125 mg and 2*25 mg) of PF-07104091 tablet Formulation B, under fasting conditions. | 0 | 30 | 0 | 30 | 18 | 30 |
| EG002 | Treatment C: PF-07104091 Tablet Formulation C (Fasted) | Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation C, under fasting conditions. | 0 | 29 | 0 | 29 | 17 | 29 |
| EG003 | Treatment D: PF-07104091 Tablet Formulation D (Fasted) | Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions. | 0 | 15 | 0 | 15 | 7 | 15 |
| EG004 | Treatment E: PF-07104091 Tablet Formulation C (Fed) | Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal. | 0 | 14 | 0 | 14 | 2 | 14 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breath odour | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Eructation | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Non-systematic Assessment |
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| Appetite disorder | Metabolism and nutrition disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 25.1 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 9, 2022 | Sep 26, 2023 | SAP_001.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|
| Ratio of adjusted geometric means |
| 98.02 |
| 2-Sided |
| 90 |
| 93.88 |
| 102.35 |
Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. |
| Other |
| Ratio of adjusted geometric means | 98.51 | 2-Sided | 90 | 91.79 | 105.73 | Values were back-transformed from the log scale. The model was a mixed effect model with sequence, period and treatment as fixed effects and participant within sequence as a random effect. | Other |
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Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal.
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Participants received a single 300 mg dose (2*125 mg and 2*25 mg) of PF-07104091 tablet Formulation B, under fasting conditions. |
| OG002 | Treatment C: PF-07104091 Tablet Formulation C (Fasted) | Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation C, under fasting conditions. |
| OG003 | Treatment D: PF-07104091 Tablet Formulation D (Fasted) | Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions. |
| OG004 | Treatment E: PF-07104091 Tablet Formulation C (Fed) | Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal. |
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| OG002 | Treatment C: PF-07104091 Tablet Formulation C (Fasted) | Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation C, under fasting conditions. |
| OG003 | Treatment D: PF-07104091 Tablet Formulation D (Fasted) | Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions. |
| OG004 | Treatment E: PF-07104091 Tablet Formulation C (Fed) | Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal. |
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| OG003 | Treatment D: PF-07104091 Tablet Formulation D (Fasted) | Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions. |
| OG004 | Treatment E: PF-07104091 Tablet Formulation C (Fed) | Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal. |
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Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation C, under fasting conditions. |
| OG003 | Treatment D: PF-07104091 Tablet Formulation D (Fasted) | Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions. |
| OG004 | Treatment E: PF-07104091 Tablet Formulation C (Fed) | Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal. |
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| Treatment C: PF-07104091 Tablet Formulation C (Fasted) |
Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation C, under fasting conditions. |
| OG003 | Treatment D: PF-07104091 Tablet Formulation D (Fasted) | Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation D, under fasting conditions. |
| OG004 | Treatment E: PF-07104091 Tablet Formulation C (Fed) | Participants received a single 300 mg dose (4*75 mg) of PF-07104091 tablet Formulation C, given with a high-fat/high-calorie meal. |
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