A Drug-Drug Interaction Study to Estimate the Effect of PF-07081532 on the Pharmacokinetics of Dabigatran and Rosuvastatin in Overweight or Obese Adult Participants

A PHASE 1, OPEN-LABEL, FIXED-SEQUENCE STUDY TO ESTIMATE THE EFFECT OF PF-07081532 ADMINISTRATION ON THE SINGLE-DOSE PHARMACOKINETICS OF DABIGATRAN AND ROSUVASTATIN IN OVERWEIGHT OR OBESE ADULT PARTICIPANTS

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05788328

Enrollment

Registered

2023-03-28

Start date

2023-03-27

Completion date

2023-09-11

Last updated

2024-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Dabigatran etexitlate, Rosuvastatin, Molecular Mechanisms of Pharmacological Action, Physiological Effects of Drugs, BCRP substrate, P-gp substrate, Anticoagulant, Antihyperlipidemic

Brief summary

The purpose of the study was to understand the effect of PF-07081532 on the movement of Dabigatran and Rosuvastatin into, though, and out of the body in healthy overweight or obese adult participants. This study also aims to collect data on safety and how tolerable the study medicine is. The study is seeking for participants who are: * Male or female who are 18 years of age or older. * Healthy but are overweight or obese. Participants will receive dabigatran and rosuvastatin as single doses by mouth 3 times during the study. The amount of the study medicine PF-07081532 will be adjusted over time until any interactions are seen. PF-07081532 is taken daily by mouth in 8 Study Periods while admitted into the study clinic over 53 days. Once discharged from the study clinic, participants will have a follow-up visit 7 to 10 days post last dose of study medicine. Then another follow-up via telephone contact, 28 to 35 days post last dose of study medicine.

Interventions

DRUGDabigatran etexilate (DE)

Dabigatran etexilate (DE) as oral capsule

DRUGRosuvastatin

Rosuvastatin as oral tablet

DRUGPF-07081532

PF-07081532 as oral tablets

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Masking description

Open label

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Otherwise healthy female and male participants must be at least 18 years of age at the time of signing the ICD (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, physical examination, including blood pressure and pulse rate measurement, standard 12-lead ECG and clinical laboratory tests) 2. BMI: ≥25.0 kg/m2 at Screening 3. Stable body weight, defined as \<5 kg change (per participant report) for 90 days before Screening

Exclusion criteria

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease 2. Diagnosis of type 1 or type 2 diabetes mellitus or secondary forms of diabetes at Screening 3. History of myocardial infarction, unstable angina, arterial revascularization, mechanical prosthetic heart valve, stroke, New York Association Functional Class II-IV heart failure, or transient ischemic attack within 6 months of Screening 4. Any malignancy not considered cured (except basal cell carcinoma and squamous cell carcinoma of the skin) 5. Personal or family history of MTC or MEN2, or study participants with suspected MTC per the investigator's judgment 6. Acute pancreatitis, a history of repeated episodes of acute pancreatitis, or history of chronic pancreatitis 7. Symptomatic gallbladder disease 8. Medical history or characteristics suggestive of genetic or syndromic obesity or obesity induced by other endocrinological disorders 9. History of depressive disorder or history of other severe psychiatric disorders within the last 2 years from Screening 10. Any lifetime history of a suicide attempt 11. Known medical history of active liver disease, or prior known drug-induced liver injury 12. History of HIV infection 13. Recent history of bleeding, or risks of bleeding, or abnormal coagulation test (INR \>1.3) result at Screening 14. Use of prohibited medications 15. Screening supine BP ≥140 mm Hg (systolic) or ≥90 mm Hg (diastolic), following at least 5 minutes of supine rest 16. Standard 12-lead ECG that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study result 17. Participants with clinical laboratory test abnormalities at Screening

Design outcomes

Primary

Measure	Time frame	Description
Area Under the Concentration-Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of Total Dabigatran in Period 1, 4 and 7	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	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.
Area Under the Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Total Dabigatran in Period 1, 4 and 7	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	AUClast was determined using the linear/log trapezoidal method.
AUCinf of Rosuvastatin in Period 2, 5 and 8	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	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.
AUClast of Rosuvastatin in Period 2, 5 and 8	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	AUClast was determined using the linear/log trapezoidal method.

Secondary

Measure	Time frame	Description
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	During treatment of the study (maximum up to 48 days)	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.
Number of Participants With Clinically Significant Vital Signs	From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)	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.
Percent Change From Baseline in Body Weight	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)	—
Number of Participants With Pre-defined Criteria of Electrocardiogram (ECG) Parameters	From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)	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.
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)	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.
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	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	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.
Maximum Observed Concentration (Cmax) of Total Dabigatran in Period 1, 4 and 7	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	—
Time for Cmax (Tmax) of Total Dabigatran in Period 1, 4 and 7	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	—
Cmax of Rosuvastatin in Period 2, 5 and 8	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	—
Apparent Volume of Distribution (Vz/F) of Total Dabigatran in Period 1, 4 and 7	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	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.
Apparent Oral Clearance (CL/F) of Total Dabigatran in Period 1, 4 and 7	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	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.
Vz/F of Rosuvastatin in Period 2, 5 and 8	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	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.
CL/F of Rosuvastatin in Period 2, 5 and 8	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	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.
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	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	—
Cmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively	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	—
Tmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively	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	—
Terminal Half-Life (t1/2) of Total Dabigatran in Period 1, 4 and 7	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	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.
Tmax of Rosuvastatin in Period 2, 5 and 8	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	—
t1/2 of Rosuvastatin in Period 2, 5 and 8	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	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.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)- All Causalities	From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)	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.

Countries

United States

Participant flow

Recruitment details

A total of 16 participants were enrolled in the study.

Pre-assignment details

Study had 8 periods and they were conducted sequentially with no washout days between the periods.

Participants by arm

Arm	Count
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.	16
Total	16

Arm

Count

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.

Total

Withdrawals & dropouts

Period	Reason	FG000
Treatment Period 4 (5 Days)	Other	1
Treatment Period 8 (4 Days)	Adverse Event	1

Baseline characteristics

Characteristic	All Participants
Age, Continuous	42.00 Years STANDARD_DEVIATION 11.34
Ethnicity (NIH/OMB) Hispanic or Latino	16 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	2 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	14 Participants
Sex: Female, Male Female	11 Participants
Sex: Female, Male Male	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk
deaths Total, all-cause mortality	0 / 16	0 / 16	0 / 16	0 / 16	0 / 15	0 / 15	0 / 15	0 / 15
other Total, other adverse events	0 / 16	0 / 16	6 / 16	15 / 16	6 / 15	15 / 15	4 / 15	9 / 15
serious Total, serious adverse events	0 / 16	0 / 16	0 / 16	0 / 16	0 / 15	0 / 15	0 / 15	1 / 15

Outcome results

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.

Time frame: 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

Population: 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.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Period 1: DE 150 mg	Area Under the Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Total Dabigatran in Period 1, 4 and 7	1326 ng*hr/mL	Geometric Coefficient of Variation 44
Period 4: DE 150 mg + PF-07081532 80 mg QD	Area Under the Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Total Dabigatran in Period 1, 4 and 7	1154 ng*hr/mL	Geometric Coefficient of Variation 39
Period 7: PF-07081532 240 mg QD + DE 150 mg	Area Under the Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Total Dabigatran in Period 1, 4 and 7	1089 ng*hr/mL	Geometric Coefficient of Variation 97

Comparison: Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.90% CI: [64.96, 112.94]

Comparison: Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.90% CI: [61.28, 106.55]

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.

Time frame: 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

Population: 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.

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Period 1: DE 150 mg	Area Under the Concentration-Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of Total Dabigatran in Period 1, 4 and 7	1359 nanogramhour/milliliter (nghr/mL)	Geometric Coefficient of Variation 43
Period 4: DE 150 mg + PF-07081532 80 mg QD	Area Under the Concentration-Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of Total Dabigatran in Period 1, 4 and 7	1195 nanogramhour/milliliter (nghr/mL)	Geometric Coefficient of Variation 38
Period 7: PF-07081532 240 mg QD + DE 150 mg	Area Under the Concentration-Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of Total Dabigatran in Period 1, 4 and 7	1141 nanogramhour/milliliter (nghr/mL)	Geometric Coefficient of Variation 92

Comparison: Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.90% CI: [66.05, 113.29]

Comparison: Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.90% CI: [63.1, 108.24]

Primary

AUCinf of Rosuvastatin in Period 2, 5 and 8

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Period 1: DE 150 mg	AUCinf of Rosuvastatin in Period 2, 5 and 8	26.86 ng*hr/mL	Geometric Coefficient of Variation 36
Period 4: DE 150 mg + PF-07081532 80 mg QD	AUCinf of Rosuvastatin in Period 2, 5 and 8	67.79 ng*hr/mL	Geometric Coefficient of Variation 58
Period 7: PF-07081532 240 mg QD + DE 150 mg	AUCinf of Rosuvastatin in Period 2, 5 and 8	63.83 ng*hr/mL	Geometric Coefficient of Variation 60

Comparison: Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.90% CI: [185.23, 283.37]

Comparison: Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.90% CI: [173.38, 265.94]

Primary

AUClast of Rosuvastatin in Period 2, 5 and 8

AUClast was determined using the linear/log trapezoidal method.

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Period 1: DE 150 mg	AUClast of Rosuvastatin in Period 2, 5 and 8	29.69 ng*hr/mL	Geometric Coefficient of Variation 47
Period 4: DE 150 mg + PF-07081532 80 mg QD	AUClast of Rosuvastatin in Period 2, 5 and 8	63.30 ng*hr/mL	Geometric Coefficient of Variation 58
Period 7: PF-07081532 240 mg QD + DE 150 mg	AUClast of Rosuvastatin in Period 2, 5 and 8	69.03 ng*hr/mL	Geometric Coefficient of Variation 68

Comparison: Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.90% CI: [170.46, 266.29]

Comparison: Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.90% CI: [185.88, 290.38]

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.

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Period 1: DE 150 mg	Apparent Oral Clearance (CL/F) of Total Dabigatran in Period 1, 4 and 7	110.3 Liters/Hours	Geometric Coefficient of Variation 43
Period 4: DE 150 mg + PF-07081532 80 mg QD	Apparent Oral Clearance (CL/F) of Total Dabigatran in Period 1, 4 and 7	125.6 Liters/Hours	Geometric Coefficient of Variation 38
Period 7: PF-07081532 240 mg QD + DE 150 mg	Apparent Oral Clearance (CL/F) of Total Dabigatran in Period 1, 4 and 7	131.5 Liters/Hours	Geometric Coefficient of Variation 92

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.

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Period 1: DE 150 mg	Apparent Volume of Distribution (Vz/F) of Total Dabigatran in Period 1, 4 and 7	1374 Liters	Geometric Coefficient of Variation 53
Period 4: DE 150 mg + PF-07081532 80 mg QD	Apparent Volume of Distribution (Vz/F) of Total Dabigatran in Period 1, 4 and 7	1618 Liters	Geometric Coefficient of Variation 48
Period 7: PF-07081532 240 mg QD + DE 150 mg	Apparent Volume of Distribution (Vz/F) of Total Dabigatran in Period 1, 4 and 7	1707 Liters	Geometric Coefficient of Variation 89

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

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Period 1: DE 150 mg	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	222000 ng*hr/mL	Geometric Coefficient of Variation 59
Period 4: DE 150 mg + PF-07081532 80 mg QD	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	701300 ng*hr/mL	Geometric Coefficient of Variation 53

Secondary

CL/F of Rosuvastatin in Period 2, 5 and 8

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Period 1: DE 150 mg	CL/F of Rosuvastatin in Period 2, 5 and 8	372.5 Liters/Hours	Geometric Coefficient of Variation 36
Period 4: DE 150 mg + PF-07081532 80 mg QD	CL/F of Rosuvastatin in Period 2, 5 and 8	147.4 Liters/Hours	Geometric Coefficient of Variation 58
Period 7: PF-07081532 240 mg QD + DE 150 mg	CL/F of Rosuvastatin in Period 2, 5 and 8	156.5 Liters/Hours	Geometric Coefficient of Variation 60

Secondary

Cmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Period 1: DE 150 mg	Cmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively	15600 ng/mL	Geometric Coefficient of Variation 49
Period 4: DE 150 mg + PF-07081532 80 mg QD	Cmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively	42730 ng/mL	Geometric Coefficient of Variation 43

Secondary

Cmax of Rosuvastatin in Period 2, 5 and 8

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Period 1: DE 150 mg	Cmax of Rosuvastatin in Period 2, 5 and 8	2.230 ng/mL	Geometric Coefficient of Variation 63
Period 4: DE 150 mg + PF-07081532 80 mg QD	Cmax of Rosuvastatin in Period 2, 5 and 8	3.951 ng/mL	Geometric Coefficient of Variation 70
Period 7: PF-07081532 240 mg QD + DE 150 mg	Cmax of Rosuvastatin in Period 2, 5 and 8	4.964 ng/mL	Geometric Coefficient of Variation 88

Comparison: Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.90% CI: [135.51, 229.6]

Comparison: Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.90% CI: [170.26, 288.48]

Secondary

Maximum Observed Concentration (Cmax) of Total Dabigatran in Period 1, 4 and 7

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Period 1: DE 150 mg	Maximum Observed Concentration (Cmax) of Total Dabigatran in Period 1, 4 and 7	186.0 ng/mL	Geometric Coefficient of Variation 54
Period 4: DE 150 mg + PF-07081532 80 mg QD	Maximum Observed Concentration (Cmax) of Total Dabigatran in Period 1, 4 and 7	86.01 ng/mL	Geometric Coefficient of Variation 48
Period 7: PF-07081532 240 mg QD + DE 150 mg	Maximum Observed Concentration (Cmax) of Total Dabigatran in Period 1, 4 and 7	90.18 ng/mL	Geometric Coefficient of Variation 104

Comparison: Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.90% CI: [33.97, 60.27]

Comparison: Analysis was performed using mixed effect model with treatment as a fixed effect and participant as a random effect.90% CI: [35.62, 63.19]

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.

Time frame: From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)

Population: 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.

Arm	Measure	Group	Value (COUNT_OF_PARTICIPANTS)
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day -1 of Period 1 (Self-injurious behavior, no suicidal intent)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day 8 of Period 3 (Completed suicide)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day 8 of Period 3 (Suicide attempt)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day 8 of Period 3 (Preparatory acts towards imminent suicidal behavior)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day 5 of Period 6 (Completed suicide)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day 5 of Period 6 (Suicide attempt)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day 5 of Period 6 (Preparatory acts towards imminent suicidal behavior)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day 5 of Period 8 (Completed suicide)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Follow-up (Preparatory acts towards imminent suicidal behavior)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Follow-up (Suicidal ideation)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Follow-up (Self-injurious behavior, no suicidal intent)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day -1 of Period 1 (Completed suicide)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day -1 of Period 1 (Suicide attempt)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day -1 of Period 1 (Preparatory acts towards imminent suicidal behavior)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day -1 of Period 1 (Suicidal ideation)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day 8 of Period 3 (Suicidal ideation)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day 8 of Period 3 (Self-injurious behavior, no suicidal intent)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day 5 of Period 6 (Suicidal ideation)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day 5 of Period 6 (Self-injurious behavior, no suicidal intent)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day 5 of Period 8 (Suicide attempt)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day 5 of Period 8 (Preparatory acts towards imminent suicidal behavior)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day 5 of Period 8 (Suicidal ideation)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Day 5 of Period 8 (Self-injurious behavior, no suicidal intent)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Follow-up (Completed suicide)	0 Participants
Period 1: DE 150 mg	Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)	Follow-up (Suicide attempt)	0 Participants

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.

Time frame: 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

Population: 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.

Arm	Measure	Group	Category	Value (COUNT_OF_PARTICIPANTS)
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Little interest/pleasure in things	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Trouble falling or staying asleep	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Feeling tired or little energy	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Moving slowly or fidgety/restless	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Little interest/pleasure in things	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Little interest/pleasure in things	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Little interest/pleasure in things	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Feeling down depressed or hopeless	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Feeling down depressed or hopeless	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Feeling down depressed or hopeless	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Poor appetite or overeating	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Poor appetite or overeating	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Trouble concentrating on things	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Trouble concentrating on things	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Little interest/pleasure in things	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Trouble falling or staying asleep	Not at all	14 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Feeling bad about yourself	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Trouble concentrating on things	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Trouble concentrating on things	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Thoughts you be better off dead	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: PHQ01- Little interest/pleasure in things	Not at all	14 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: PHQ01- Little interest/pleasure in things	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Feeling down depressed or hopeless	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Feeling down depressed or hopeless	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Feeling down depressed or hopeless	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Trouble falling or staying asleep	Several days	2 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Trouble falling or staying asleep	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Feeling tired or little energy	Not at all	11 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Feeling tired or little energy	Several days	3 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Feeling tired or little energy	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Poor appetite or overeating	Several days	5 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Poor appetite or overeating	More than half the days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Feeling bad about yourself	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Trouble concentrating on things	Not at all	14 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Trouble concentrating on things	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Trouble concentrating on things	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Moving slowly or fidgety/restless	Not at all	14 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Thoughts you be better off dead	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Little interest/pleasure in things	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Feeling down depressed or hopeless	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Feeling down depressed or hopeless	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Feeling down depressed or hopeless	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Trouble falling or staying asleep	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Thoughts you be better off dead	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-Up: Little interest/pleasure in things	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Trouble falling or staying asleep	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Poor appetite or overeating	Not at all	11 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Poor appetite or overeating	Nearly every day	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Trouble concentrating on things	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Trouble concentrating on things	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Moving slowly or fidgety/restless	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Trouble falling or staying asleep	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Trouble falling or staying asleep	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Trouble falling or staying asleep	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Trouble falling or staying asleep	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Feeling tired or little energy	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Feeling tired or little energy	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Feeling tired or little energy	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Feeling tired or little energy	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Poor appetite or overeating	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Poor appetite or overeating	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Feeling bad about yourself	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Feeling bad about yourself	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Feeling bad about yourself	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Feeling bad about yourself	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Trouble concentrating on things	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Trouble concentrating on things	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Moving slowly or fidgety/restless	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Moving slowly or fidgety/restless	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Moving slowly or fidgety/restless	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Moving slowly or fidgety/restless	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Thoughts you be better off dead	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Thoughts you be better off dead	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Thoughts you be better off dead	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Thoughts you be better off dead	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Little interest/pleasure in things	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Little interest/pleasure in things	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Little interest/pleasure in things	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Feeling down depressed or hopeless	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Feeling down depressed or hopeless	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Feeling down depressed or hopeless	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Feeling down depressed or hopeless	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Trouble falling or staying asleep	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Trouble falling or staying asleep	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Trouble falling or staying asleep	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Feeling tired or little energy	Not at all	14 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Feeling tired or little energy	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Feeling tired or little energy	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Feeling tired or little energy	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Poor appetite or overeating	Not at all	8 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Poor appetite or overeating	Several days	4 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Poor appetite or overeating	More than half the days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Poor appetite or overeating	Nearly every day	2 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Feeling bad about yourself	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Feeling bad about yourself	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Feeling bad about yourself	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Trouble concentrating on things	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Trouble concentrating on things	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Moving slowly or fidgety/restless	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Moving slowly or fidgety/restless	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Moving slowly or fidgety/restless	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Moving slowly or fidgety/restless	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Thoughts you be better off dead	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Thoughts you be better off dead	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 6: Thoughts you be better off dead	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: PHQ01- Little interest/pleasure in things	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: PHQ01- Little interest/pleasure in things	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Feeling down depressed or hopeless	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Trouble falling or staying asleep	Not at all	13 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Trouble falling or staying asleep	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Feeling tired or little energy	Nearly every day	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Poor appetite or overeating	Not at all	5 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Poor appetite or overeating	Nearly every day	4 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Feeling bad about yourself	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Feeling bad about yourself	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Feeling bad about yourself	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Trouble concentrating on things	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Moving slowly or fidgety/restless	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Moving slowly or fidgety/restless	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Moving slowly or fidgety/restless	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Thoughts you be better off dead	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Thoughts you be better off dead	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 1 of Period 8: Thoughts you be better off dead	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Little interest/pleasure in things	Not at all	14 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Little interest/pleasure in things	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Little interest/pleasure in things	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Feeling down depressed or hopeless	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Trouble falling or staying asleep	Not at all	13 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Trouble falling or staying asleep	Several days	2 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Trouble falling or staying asleep	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Feeling tired or little energy	Not at all	10 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Feeling tired or little energy	Several days	3 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Feeling tired or little energy	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Feeling tired or little energy	Nearly every day	2 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Poor appetite or overeating	Not at all	6 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Poor appetite or overeating	Several days	6 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Poor appetite or overeating	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Poor appetite or overeating	Nearly every day	3 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Feeling bad about yourself	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Feeling bad about yourself	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Feeling bad about yourself	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Feeling bad about yourself	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Trouble concentrating on things	Not at all	14 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Trouble concentrating on things	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Trouble concentrating on things	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Trouble concentrating on things	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Moving slowly or fidgety/restless	Not at all	14 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Moving slowly or fidgety/restless	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Moving slowly or fidgety/restless	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Moving slowly or fidgety/restless	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Thoughts you be better off dead	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Thoughts you be better off dead	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 5 of Period 8: Thoughts you be better off dead	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-Up: Little interest/pleasure in things	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-Up: Little interest/pleasure in things	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-Up: Little interest/pleasure in things	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Feeling down depressed or hopeless	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Feeling down depressed or hopeless	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Feeling down depressed or hopeless	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Feeling down depressed or hopeless	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Trouble falling or staying asleep	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Trouble falling or staying asleep	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Trouble falling or staying asleep	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Feeling tired or little energy	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Feeling tired or little energy	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Feeling tired or little energy	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Feeling tired or little energy	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Poor appetite or overeating	Several days	3 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Poor appetite or overeating	More than half the days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Feeling bad about yourself	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Feeling bad about yourself	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Feeling bad about yourself	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Feeling bad about yourself	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Trouble concentrating on things	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Trouble concentrating on things	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Moving slowly or fidgety/restless	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Moving slowly or fidgety/restless	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Moving slowly or fidgety/restless	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Thoughts you be better off dead	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Thoughts you be better off dead	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Thoughts you be better off dead	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Follow-up: Thoughts you be better off dead	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Little interest/pleasure in things	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Little interest/pleasure in things	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Little interest/pleasure in things	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Feeling down depressed or hopeless	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Feeling down depressed or hopeless	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Feeling down depressed or hopeless	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Feeling down depressed or hopeless	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Trouble falling or staying asleep	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Trouble falling or staying asleep	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Trouble falling or staying asleep	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Feeling tired or little energy	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Feeling tired or little energy	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Feeling tired or little energy	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Poor appetite or overeating	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Poor appetite or overeating	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Poor appetite or overeating	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Poor appetite or overeating	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Feeling bad about yourself	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Feeling bad about yourself	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Feeling bad about yourself	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Feeling bad about yourself	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Trouble concentrating on things	Not at all	15 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Trouble concentrating on things	Several days	1 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Moving slowly or fidgety/restless	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Trouble concentrating on things	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Trouble concentrating on things	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Moving slowly or fidgety/restless	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Moving slowly or fidgety/restless	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Thoughts You be better off dead	Not at all	16 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Thoughts You be better off dead	Several days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Thoughts You be better off dead	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day -1 of Period 1: Thoughts You be better off dead	Nearly every day	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Little interest/pleasure in things	More than half the days	0 Participants
Period 1: DE 150 mg	Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification	Day 8 of Period 3: Feeling down depressed or hopeless	Not at all	16 Participants

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.

Time frame: From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Period 1: DE 150 mg	Number of Participants With Clinically Significant Vital Signs	0 Participants
Period 4: DE 150 mg + PF-07081532 80 mg QD	Number of Participants With Clinically Significant Vital Signs	0 Participants
Period 7: PF-07081532 240 mg QD + DE 150 mg	Number of Participants With Clinically Significant Vital Signs	0 Participants
Period 4: DE 150 mg + PF-07081532 80 mg QD	Number of Participants With Clinically Significant Vital Signs	0 Participants
Period 5: ROSU 10mg + PF-07081532 80 mg QD	Number of Participants With Clinically Significant Vital Signs	0 Participants
Period 6: PF-07081532 240 mg QD	Number of Participants With Clinically Significant Vital Signs	0 Participants
Period 7: PF-07081532 240 mg QD + DE 150 mg	Number of Participants With Clinically Significant Vital Signs	0 Participants
Period 8: PF-07081532 240 mg QD + ROSU 10 mg	Number of Participants With Clinically Significant Vital Signs	0 Participants

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.

Time frame: During treatment of the study (maximum up to 48 days)

Population: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Period 1: DE 150 mg	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	2 Participants
Period 4: DE 150 mg + PF-07081532 80 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	1 Participants
Period 7: PF-07081532 240 mg QD + DE 150 mg	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	1 Participants
Period 4: DE 150 mg + PF-07081532 80 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	2 Participants
Period 5: ROSU 10mg + PF-07081532 80 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	3 Participants
Period 6: PF-07081532 240 mg QD	Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)	15 Participants

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.

Time frame: From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)

Population: 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.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Period 1: DE 150 mg	Number of Participants With Pre-defined Criteria of Electrocardiogram (ECG) Parameters	0 Participants
Period 4: DE 150 mg + PF-07081532 80 mg QD	Number of Participants With Pre-defined Criteria of Electrocardiogram (ECG) Parameters	0 Participants
Period 7: PF-07081532 240 mg QD + DE 150 mg	Number of Participants With Pre-defined Criteria of Electrocardiogram (ECG) Parameters	0 Participants
Period 4: DE 150 mg + PF-07081532 80 mg QD	Number of Participants With Pre-defined Criteria of Electrocardiogram (ECG) Parameters	0 Participants
Period 5: ROSU 10mg + PF-07081532 80 mg QD	Number of Participants With Pre-defined Criteria of Electrocardiogram (ECG) Parameters	0 Participants

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.

Time frame: From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)

Population: Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Period 1: DE 150 mg	Number of Participants With Treatment Emergent Adverse Events (TEAEs)- All Causalities	0 Participants
Period 4: DE 150 mg + PF-07081532 80 mg QD	Number of Participants With Treatment Emergent Adverse Events (TEAEs)- All Causalities	0 Participants
Period 7: PF-07081532 240 mg QD + DE 150 mg	Number of Participants With Treatment Emergent Adverse Events (TEAEs)- All Causalities	6 Participants
Period 4: DE 150 mg + PF-07081532 80 mg QD	Number of Participants With Treatment Emergent Adverse Events (TEAEs)- All Causalities	15 Participants
Period 5: ROSU 10mg + PF-07081532 80 mg QD	Number of Participants With Treatment Emergent Adverse Events (TEAEs)- All Causalities	6 Participants
Period 6: PF-07081532 240 mg QD	Number of Participants With Treatment Emergent Adverse Events (TEAEs)- All Causalities	15 Participants
Period 7: PF-07081532 240 mg QD + DE 150 mg	Number of Participants With Treatment Emergent Adverse Events (TEAEs)- All Causalities	4 Participants
Period 8: PF-07081532 240 mg QD + ROSU 10 mg	Number of Participants With Treatment Emergent Adverse Events (TEAEs)- All Causalities	9 Participants

Secondary

Percent Change From Baseline in Body Weight

Time frame: 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)

Population: 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.

Arm	Measure	Group	Value (MEAN)	Dispersion
Period 1: DE 150 mg	Percent Change From Baseline in Body Weight	Day 5 of Period 6	-3.32 Percent change	Standard Deviation 2.17
Period 1: DE 150 mg	Percent Change From Baseline in Body Weight	Day 12 of Period 6	-4.82 Percent change	Standard Deviation 2.276
Period 1: DE 150 mg	Percent Change From Baseline in Body Weight	Day 1 of Period 3	-0.51 Percent change	Standard Deviation 0.95
Period 1: DE 150 mg	Percent Change From Baseline in Body Weight	Day 8 of Period 3	-1.02 Percent change	Standard Deviation 1.559
Period 1: DE 150 mg	Percent Change From Baseline in Body Weight	Day 1 of Period 5	-2.58 Percent change	Standard Deviation 2.146
Period 1: DE 150 mg	Percent Change From Baseline in Body Weight	Day 1 of Period 8	-6.52 Percent change	Standard Deviation 3.272
Period 1: DE 150 mg	Percent Change From Baseline in Body Weight	Day 5 of Period 8	-6.90 Percent change	Standard Deviation 2.778
Period 1: DE 150 mg	Percent Change From Baseline in Body Weight	Follow-up	-6.01 Percent change	Standard Deviation 3.327

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.

Time frame: 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

Arm	Measure	Value (MEAN)	Dispersion
Period 1: DE 150 mg	t1/2 of Rosuvastatin in Period 2, 5 and 8	25.40 Hours	Standard Deviation 9.2472
Period 4: DE 150 mg + PF-07081532 80 mg QD	t1/2 of Rosuvastatin in Period 2, 5 and 8	25.52 Hours	Standard Deviation 16.897
Period 7: PF-07081532 240 mg QD + DE 150 mg	t1/2 of Rosuvastatin in Period 2, 5 and 8	19.06 Hours	Standard Deviation 5.0112

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.

Time frame: 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

Arm	Measure	Value (MEAN)	Dispersion
Period 1: DE 150 mg	Terminal Half-Life (t1/2) of Total Dabigatran in Period 1, 4 and 7	8.921 Hours	Standard Deviation 2.8387
Period 4: DE 150 mg + PF-07081532 80 mg QD	Terminal Half-Life (t1/2) of Total Dabigatran in Period 1, 4 and 7	9.023 Hours	Standard Deviation 1.3586
Period 7: PF-07081532 240 mg QD + DE 150 mg	Terminal Half-Life (t1/2) of Total Dabigatran in Period 1, 4 and 7	9.208 Hours	Standard Deviation 2.0514

Secondary

Time for Cmax (Tmax) of Total Dabigatran in Period 1, 4 and 7

Time frame: 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

Arm	Measure	Value (MEDIAN)
Period 1: DE 150 mg	Time for Cmax (Tmax) of Total Dabigatran in Period 1, 4 and 7	3.00 Hours
Period 4: DE 150 mg + PF-07081532 80 mg QD	Time for Cmax (Tmax) of Total Dabigatran in Period 1, 4 and 7	6.00 Hours
Period 7: PF-07081532 240 mg QD + DE 150 mg	Time for Cmax (Tmax) of Total Dabigatran in Period 1, 4 and 7	6.00 Hours

Secondary

Tmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively

Time frame: 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

Arm	Measure	Value (MEDIAN)
Period 1: DE 150 mg	Tmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively	6.00 Hours
Period 4: DE 150 mg + PF-07081532 80 mg QD	Tmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively	4.00 Hours

Secondary

Tmax of Rosuvastatin in Period 2, 5 and 8

Time frame: 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

Arm	Measure	Value (MEDIAN)
Period 1: DE 150 mg	Tmax of Rosuvastatin in Period 2, 5 and 8	5.00 Hours
Period 4: DE 150 mg + PF-07081532 80 mg QD	Tmax of Rosuvastatin in Period 2, 5 and 8	5.00 Hours
Period 7: PF-07081532 240 mg QD + DE 150 mg	Tmax of Rosuvastatin in Period 2, 5 and 8	5.00 Hours

Secondary

Vz/F of Rosuvastatin in Period 2, 5 and 8

Time frame: 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

Arm	Measure	Value (GEOMETRIC_MEAN)	Dispersion
Period 1: DE 150 mg	Vz/F of Rosuvastatin in Period 2, 5 and 8	12900 Liters	Geometric Coefficient of Variation 45
Period 4: DE 150 mg + PF-07081532 80 mg QD	Vz/F of Rosuvastatin in Period 2, 5 and 8	4753 Liters	Geometric Coefficient of Variation 88
Period 7: PF-07081532 240 mg QD + DE 150 mg	Vz/F of Rosuvastatin in Period 2, 5 and 8	4171 Liters	Geometric Coefficient of Variation 63

Source: ClinicalTrials.gov · Data processed: May 1, 2026

A Drug-Drug Interaction Study to Estimate the Effect of PF-07081532 on the Pharmacokinetics of Dabigatran and Rosuvastatin in Overweight or Obese Adult Participants

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Area Under the Concentration-Time Curve From Time 0 to the Last Measurable Concentration (AUClast) of Total Dabigatran in Period 1, 4 and 7

Area Under the Concentration-Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of Total Dabigatran in Period 1, 4 and 7

AUCinf of Rosuvastatin in Period 2, 5 and 8

AUClast of Rosuvastatin in Period 2, 5 and 8

Apparent Oral Clearance (CL/F) of Total Dabigatran in Period 1, 4 and 7

Apparent Volume of Distribution (Vz/F) of Total Dabigatran in Period 1, 4 and 7

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

CL/F of Rosuvastatin in Period 2, 5 and 8

Cmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively

Cmax of Rosuvastatin in Period 2, 5 and 8

Maximum Observed Concentration (Cmax) of Total Dabigatran in Period 1, 4 and 7

Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)

Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification

Number of Participants With Clinically Significant Vital Signs

Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)

Number of Participants With Pre-defined Criteria of Electrocardiogram (ECG) Parameters

Number of Participants With Treatment Emergent Adverse Events (TEAEs)- All Causalities

Percent Change From Baseline in Body Weight

t1/2 of Rosuvastatin in Period 2, 5 and 8

Terminal Half-Life (t1/2) of Total Dabigatran in Period 1, 4 and 7

Time for Cmax (Tmax) of Total Dabigatran in Period 1, 4 and 7

Tmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively

Tmax of Rosuvastatin in Period 2, 5 and 8

Vz/F of Rosuvastatin in Period 2, 5 and 8