| Primary | Area Under the Concentration-Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of Total Dabigatran in Period 1, 4 and 7 | AUCinf was calculated as AUClast + (Clast/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast), Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is first-order elimination rate constant. | Pharmacokinetic (PK) parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 1, 4 and 7 only. | Posted | | Geometric Mean | Geometric Coefficient of Variation | nanogram*hour/milliliter (ng*hr/mL) | | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Period 1: DE 150 mg | Participants received DE 150 mg as single oral dose on Day 1 of Period 1. | | OG001 | Period 4: DE 150 mg + PF-07081532 80 mg QD | Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4. | | OG002 | Period 7: PF-07081532 240 mg QD + DE 150 mg | Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0001359± 43
- OG0011195± 38
- OG0021141± 92
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect. | | | | | Ratio of Adjusted Geometric Means | 86.50 | | | 2-Sided | 90 | 66.05 | 113.29 | | | Ratio was of test to reference of adjusted geometric means. Reference arm was DE 150mg (Period 1) and test arm was PF-07081532 80mg QD + DE 150mg (Period 4). Ratios (and 90% CIs) were expressed as percentages. | | Other | | | |
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| Primary | Area Under the Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Total Dabigatran in Period 1, 4 and 7 | AUClast was determined using the linear/log trapezoidal method. | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 1, 4 and 7 only. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Period 1: DE 150 mg | Participants received DE 150 mg as single oral dose on Day 1 of Period 1. | | OG001 | Period 4: DE 150 mg + PF-07081532 80 mg QD | Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4. | | OG002 | Period 7: PF-07081532 240 mg QD + DE 150 mg | Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7. |
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| Primary | AUCinf of Rosuvastatin in Period 2, 5 and 8 | AUCinf was calculated as AUClast + (Clast/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast), Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is first-order elimination rate constant. | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 2, 5 and 8 only. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Period 2: ROSU 10 mg | Participants received ROSU 10 mg as single dose on Day 1 of Period 2. | | OG001 | Period 5: ROSU 10mg + PF-07081532 80 mg QD | Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5. | | OG002 | Period 8: PF-07081532 240 mg QD + ROSU 10 mg |
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| Primary | AUClast of Rosuvastatin in Period 2, 5 and 8 | AUClast was determined using the linear/log trapezoidal method. | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 2, 5 and 8 only. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Period 2: ROSU 10 mg | Participants received ROSU 10 mg as single dose on Day 1 of Period 2. | | OG001 | Period 5: ROSU 10mg + PF-07081532 80 mg QD | Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5. | | OG002 | Period 8: PF-07081532 240 mg QD + ROSU 10 mg | Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8. |
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| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs)- All Causalities | An adverse event (AE) was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. TEAEs were any untoward medical incidence in a participant during administered study intervention, whether or not these events are related to study intervention. AEs included both serious adverse events (SAEs) and all non-SAEs. An SAE was any untoward medical occurrence at any dose that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity and lastly causes a congenital anomaly/birth defect. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: DE 150 mg | Participants received DE 150 mg as single oral dose on Day 1 of Period 1. | | OG001 | Period 2: ROSU 10 mg | Participants received ROSU 10 mg as single dose on Day 1 of Period 2. | | OG002 |
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| Secondary | Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) | The following laboratory parameters were assessed according to pre-specified criteria for abnormalities: a) hematology; erythrocytes mean corpuscular hemoglobin (picograms per cells ([pg/cells]) (less than[<]0.9*lower limit of normal [LLN]), eosinophils (10^9/Liter [L]), (more than[>]1.2*upper limit of normal [ULN]), prothrombin time (seconds)(>1.1*ULN), prothrombin international normalized ratio(>1.1*ULN); b) clinical chemistry; direct bilirubin(milligram per deciliter [mg/dL])(>1.5*ULN), aspartate aminotransferase(units per litre [U/L]) (>3.0*ULN), alanine aminotransferase(U/L)(> 3.0*ULN), gamma glutamyl transferase(U/L)(> 3.0*ULN), urate (mg/dL)(> 1.2*ULN), high density lipoprotein(HDL) cholesterol (mg/dl)(<0.8*LLN) and lipase(U/L)(> 1.5*ULN). Number of participants with any laboratory abnormalities (without regard to baseline abnormality) meeting pre-specified criteria are reported in this outcome measure. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. No laboratory blood sample draws were planned in Period 1 and Period 2, thus no laboratory abnormalities data were collected for these 2 periods. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | During treatment of the study (maximum up to 48 days) | | | | ID | Title | Description |
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| OG000 | Period 3: PF-07081532 40 mg QD | Participants received oral PF-07081532 titrated from 20 mg up to 40 mg QD for 8 days in Period 3. |
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| Secondary | Number of Participants With Clinically Significant Vital Signs | Vital signs measurement included blood pressure (systolic blood pressure [SBP], diastolic blood pressure [DBP] and pulse rate (PR) and were measured in a supine position after approximately 5 minutes of rest for the participant. Clinical significance in vital signs was judged by investigator. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. | Posted | | Count of Participants | | Participants | | From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: DE 150 mg | Participants received DE 150 mg as single oral dose on Day 1 of Period 1. | | OG001 | Period 2: ROSU 10 mg | Participants received ROSU 10 mg as single dose on Day 1 of Period 2. | | OG002 | Period 3: PF-07081532 40 mg QD | Participants received oral PF-07081532 titrated from 20 mg up to 40 mg QD for 8 days in Period 3. | | OG003 | Period 4: DE 150 mg + PF-07081532 80 mg QD |
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| Secondary | Percent Change From Baseline in Body Weight | | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable body weight were analyzed and reported under 'All participants' in this outcome measure. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Percent change | | Baseline, Day 1 and 8 of Period 3, Day 1 of Period 5, Day 5 and 12 of Period 6, Day 1 and 5 of Period 8 and follow-up (28-35 days post last dose; up to 76 to 83 days) | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Participants received DE 150 mg as single oral dose on Day 1 of Period 1 followed by ROSU 10 mg as single dose on Day 1 of Period 2 followed by oral PF-07081532 titrated from 20 mg up to 40 mg QD for 8 days in Period 3 followed by DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally for 5 days in Period 4. Participants then received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally for 4 days in Period 5 followed by oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6 followed by DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally for 2 days in Period 7 followed by ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally for 4 days in Period 8.There was no washout periods between the study. |
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| Secondary | Number of Participants With Pre-defined Criteria of Electrocardiogram (ECG) Parameters | Pre-defined criteria for ECG abnormalities included: PR interval aggregate (millisecond [msec], max. >=300; baseline > 200 and max. increase >= 25 percent (%); baseline > 200 and max. increase >= 25%), QRS interval (msec, max >=140; max. increase >= 50%), QT interval correct by Frederica formula (QTCF) interval aggregate (msec, 450 < max <= 480; 480 < max. <= 500; max. > 500; 30 < max. increase <= 60; max. increase > 60). Number of participants with at least 1 ECG abnormality are reported in this outcome measure. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 1, 3, 4, 6 and 8 only. | Posted | | Count of Participants | | Participants | | From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days) | | | | ID | Title | Description |
|---|
| OG000 | Period 1: DE 150 mg | Participants received DE 150 mg as single oral dose on Day 1 of Period 1. | | OG001 | Period 3: PF-07081532 40 mg QD | Participants received oral PF-07081532 titrated from 20 mg up to 40 mg once daily (QD) for 8 days in Period 3. |
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| Secondary | Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. Yes/No responses are mapped to Columbia classification algorithm of suicide assessment (C-CASA) categories: completed suicide, suicide attempt, preparatory acts toward imminent suicidal behavior, suicidal ideation, and self-injurious behavior, or no suicidal intent. n this outcome measure, number of participants with positive response (response of "yes") for each of the five categories are reported. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable C-SSRS were analyzed and reported under 'All participants' in this outcome measure. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days) | | | | ID | Title | Description |
|---|
| OG000 | All Participants | Participants received DE 150 mg as single oral dose on Day 1 of Period 1 followed by ROSU 10 mg as single dose on Day 1 of Period 2 followed by oral PF-07081532 titrated from 20 mg up to 40 mg QD for 8 days in Period 3 followed by DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally for 5 days in Period 4. Participants then received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally for 4 days in Period 5 followed by oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6 followed by DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally for 2 days in Period 7 followed by ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally for 4 days in Period 8.There was no washout periods between the study. |
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| Secondary | Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification | The PHQ-9 is a 9 item self-report scale for the assessment of depressive symptoms. The questions included "little interest/pleasure in things", "feeling down depressed or hopeless", "trouble falling or staying asleep", "feeling tired or little energy", "poor appetite or overeating", "feeling bad about yourself", "trouble concentrating on things", "moving slowly or fidgety/restless" and "thoughts you be better off dead". Each item was scored on scale of "not at all" (0), "several days" (1), "more than half the days" (2) to "nearly every day" (3). Total score was obtained by addition of scores for each item and resulted into overall possible score range of 0-27. Higher score = greater severity. | Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable PHQ-9 were analyzed and reported under 'All participants' in this outcome measure. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. | Posted | | Count of Participants | | Participants | | Day 1 prior to treatment (Day -1) in Period 1; Day 8 of Period 3; Days 5 of Period 6; Day 1 and 5 of Period 8; Follow-up: up to 53 to 56 days post last dose of study intervention | | | | ID | Title | Description |
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| OG000 | All Participants | Participants received Dabigatran etexilate (DE ) 150 milligram (mg) as single oral dose on Day 1 of Period 1 followed by Rosuvastatin (ROSU ) 10 mg as single dose on Day 1 of Period 2 followed by oral PF-07081532 titrated from 20 mg up to 40 mg once daily (QD) for 8 days in Period 3 followed by DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally for 5 days in Period 4. Participants then received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally for 4 days in Period 5 followed by oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6 followed by DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally for 2 days in Period 7 followed by ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally for 4 days in Period 8.There was no washout periods between the study. |
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| Secondary | Maximum Observed Concentration (Cmax) of Total Dabigatran in Period 1, 4 and 7 | | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 1, 4 and 7 only. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Period 1: DE 150 mg | Participants received DE 150 mg as single oral dose on Day 1 of Period 1. | | OG001 | Period 4: DE 150 mg + PF-07081532 80 mg QD | Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4. | | OG002 | Period 7: PF-07081532 240 mg QD + DE 150 mg | Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7. |
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| Secondary | Time for Cmax (Tmax) of Total Dabigatran in Period 1, 4 and 7 | | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 1, 4 and 7 only. | Posted | | Median | Full Range | Hours | | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Period 1: DE 150 mg | Participants received DE 150 mg as single oral dose on Day 1 of Period 1. | | OG001 | Period 4: DE 150 mg + PF-07081532 80 mg QD | Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4. | | OG002 | Period 7: PF-07081532 240 mg QD + DE 150 mg | Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7. |
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| Secondary | Terminal Half-Life (t1/2) of Total Dabigatran in Period 1, 4 and 7 | T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 1, 4 and 7 only. | Posted | | Mean | Standard Deviation | Hours | | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Period 1: DE 150 mg | Participants received DE 150 mg as single oral dose on Day 1 of Period 1. | | OG001 | Period 4: DE 150 mg + PF-07081532 80 mg QD | Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4. | | OG002 | Period 7: PF-07081532 240 mg QD + DE 150 mg | Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7. |
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| Secondary | Apparent Volume of Distribution (Vz/F) of Total Dabigatran in Period 1, 4 and 7 | Vz/F was calculated as dose/(AUCinf*kel). AUCinf was calculated as AUClast + (Clast/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast), Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is first-order elimination rate constant. | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 1, 4 and 7 only. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Period 1: DE 150 mg | Participants received DE 150 mg as single oral dose on Day 1 of Period 1. | | OG001 | Period 4: DE 150 mg + PF-07081532 80 mg QD | Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4. | |
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| Secondary | Apparent Oral Clearance (CL/F) of Total Dabigatran in Period 1, 4 and 7 | CL/F was calculated as dose/AUCinf. AUCinf was calculated as AUClast + (Clast/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast), Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is first-order elimination rate constant. | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 1, 4 and 7 only. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters/Hours | | Pre-dose (0 hour), 0.5, 1, 2, 3, 4, 6, 8, 12, 24 and 48 hours post dose of DE on Day 1 of Period 1, 4 and 7 | | | | ID | Title | Description |
|---|
| OG000 | Period 1: DE 150 mg | Participants received DE 150 mg as single oral dose on Day 1 of Period 1. | | OG001 | Period 4: DE 150 mg + PF-07081532 80 mg QD | Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4. | | OG002 |
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| Secondary | Cmax of Rosuvastatin in Period 2, 5 and 8 | | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 2, 5 and 8 only. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Period 2: ROSU 10 mg | Participants received ROSU 10 mg as single dose on Day 1 of Period 2. | | OG001 | Period 5: ROSU 10mg + PF-07081532 80 mg QD | Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5. | | OG002 | Period 8: PF-07081532 240 mg QD + ROSU 10 mg | Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8. |
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| Secondary | Tmax of Rosuvastatin in Period 2, 5 and 8 | | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 2, 5 and 8 only. | Posted | | Median | Full Range | Hours | | Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Period 2: ROSU 10 mg | Participants received ROSU 10 mg as single dose on Day 1 of Period 2. | | OG001 | Period 5: ROSU 10mg + PF-07081532 80 mg QD | Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5. | | OG002 | Period 8: PF-07081532 240 mg QD + ROSU 10 mg | Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8. |
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| Secondary | t1/2 of Rosuvastatin in Period 2, 5 and 8 | T1/2 was calculated as loge(2)/kel, where kel is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve. | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 2, 5 and 8 only. | Posted | | Mean | Standard Deviation | Hours | | Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Period 2: ROSU 10 mg | Participants received ROSU 10 mg as single dose on Day 1 of Period 2. | | OG001 | Period 5: ROSU 10mg + PF-07081532 80 mg QD | Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5. | | OG002 | Period 8: PF-07081532 240 mg QD + ROSU 10 mg | Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8. |
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| Secondary | Vz/F of Rosuvastatin in Period 2, 5 and 8 | Vz/F was calculated as dose/(AUCinf*kel). AUCinf was calculated as AUClast + (Clast/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast), Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is first-order elimination rate constant. | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 2, 5 and 8 only. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters | | Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8 | | | | ID | Title | Description |
|---|
| OG000 | Period 2: ROSU 10 mg | Participants received ROSU 10 mg as single dose on Day 1 of Period 2. | | OG001 | Period 5: ROSU 10mg + PF-07081532 80 mg QD | Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5. | | OG002 |
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| Secondary | CL/F of Rosuvastatin in Period 2, 5 and 8 | CL/F was calculated as dose/AUCinf. AUCinf was calculated as AUClast + (Clast/kel), where AUClast is area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast), Clast is the predicted plasma concentration at the last quantifiable time point from the log-linear regression analysis and kel is first-order elimination rate constant. | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 2, 5 and 8 only. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Liters/Hours | | Pre-dose (0 hour), 1, 2, 3, 4, 5, 6, 8, 10, 14, 24, 48, 72 and 96 hours post dose of ROSU on Day 1 of Period 2, 5 and 8 | | | | ID | Title | Description |
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| OG000 | Period 2: ROSU 10 mg | Participants received ROSU 10 mg as single dose on Day 1 of Period 2. | | OG001 | Period 5: ROSU 10mg + PF-07081532 80 mg QD | Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5. | | OG002 |
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| Secondary | Area Under the Concentration-Time Curve From Time 0 to Time 24 Hours (AUC24) of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively | | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 4 and 8 only. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng*hr/mL | | Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 14 and 24 hours post dose of PF-07081532 in Period 4 and 8 | | | | ID | Title | Description |
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| OG000 | Period 4: DE 150 mg + PF-07081532 80 mg QD | Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4. | | OG001 | Period 8: PF-07081532 240 mg QD + ROSU 10 mg | Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8. |
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| Secondary | Cmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively | | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 4 and 8 only. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ng/mL | | Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 14 and 24 hours post dose of PF-07081532 in Period 4 and 8 | | | | ID | Title | Description |
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| OG000 | Period 4: DE 150 mg + PF-07081532 80 mg QD | Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4. | | OG001 | Period 8: PF-07081532 240 mg QD + ROSU 10 mg | Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8. |
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| Secondary | Tmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively | | PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 4 and 8 only. | Posted | | Median | Full Range | Hours | | Pre-dose (0 hour), 0.5, 1, 2, 4, 6, 8, 10, 14 and 24 hours post dose of PF-07081532 in Period 4 and 8 | | | | ID | Title | Description |
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| OG000 | Period 4: DE 150 mg + PF-07081532 80 mg QD | Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4. | | OG001 | Period 8: PF-07081532 240 mg QD + ROSU 10 mg | Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8. |
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