Trial Outcomes & Findings for 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 (NCT NCT05788328)
NCT ID: NCT05788328
Last Updated: 2024-11-15
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
16 participants
Primary outcome timeframe
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
Results posted on
2024-11-15
Participant Flow
A total of 16 participants were enrolled in the study.
Study had 8 periods and they were conducted sequentially with no washout days between the periods.
Participant milestones
| Measure |
All Participants
Participants received Dabigatran etexilate (DE) 150 milligram (mg) as single oral dose on Day 1 of Period 1 followed by Rosuvastatin (ROSU) 10 mg as single dose on Day 1 of Period 2 followed by oral PF-07081532 titrated from 20 mg up to 40 mg once daily (QD) for 8 days in Period 3 followed by DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally for 5 days in Period 4. Participants then received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally for 4 days in Period 5 followed by oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6 followed by DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally for 2 days in Period 7 followed by ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally for 4 days in Period 8.There was no washout periods between the study.
|
|---|---|
|
Treatment Period 1 (3 Days)
STARTED
|
16
|
|
Treatment Period 1 (3 Days)
COMPLETED
|
16
|
|
Treatment Period 1 (3 Days)
NOT COMPLETED
|
0
|
|
Treatment Period 2 (4 Days)
STARTED
|
16
|
|
Treatment Period 2 (4 Days)
COMPLETED
|
16
|
|
Treatment Period 2 (4 Days)
NOT COMPLETED
|
0
|
|
Treatment Period 3 (8 Days)
STARTED
|
16
|
|
Treatment Period 3 (8 Days)
COMPLETED
|
16
|
|
Treatment Period 3 (8 Days)
NOT COMPLETED
|
0
|
|
Treatment Period 4 (5 Days)
STARTED
|
16
|
|
Treatment Period 4 (5 Days)
COMPLETED
|
15
|
|
Treatment Period 4 (5 Days)
NOT COMPLETED
|
1
|
|
Treatment Period 5 (4 Days)
STARTED
|
15
|
|
Treatment Period 5 (4 Days)
COMPLETED
|
15
|
|
Treatment Period 5 (4 Days)
NOT COMPLETED
|
0
|
|
Treatment Period 6 (17 Days)
STARTED
|
15
|
|
Treatment Period 6 (17 Days)
COMPLETED
|
15
|
|
Treatment Period 6 (17 Days)
NOT COMPLETED
|
0
|
|
Treatment Period 7 (2 Days)
STARTED
|
15
|
|
Treatment Period 7 (2 Days)
COMPLETED
|
15
|
|
Treatment Period 7 (2 Days)
NOT COMPLETED
|
0
|
|
Treatment Period 8 (4 Days)
STARTED
|
15
|
|
Treatment Period 8 (4 Days)
COMPLETED
|
14
|
|
Treatment Period 8 (4 Days)
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Participants
Participants received Dabigatran etexilate (DE) 150 milligram (mg) as single oral dose on Day 1 of Period 1 followed by Rosuvastatin (ROSU) 10 mg as single dose on Day 1 of Period 2 followed by oral PF-07081532 titrated from 20 mg up to 40 mg once daily (QD) for 8 days in Period 3 followed by DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally for 5 days in Period 4. Participants then received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally for 4 days in Period 5 followed by oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6 followed by DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally for 2 days in Period 7 followed by ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally for 4 days in Period 8.There was no washout periods between the study.
|
|---|---|
|
Treatment Period 4 (5 Days)
Other
|
1
|
|
Treatment Period 8 (4 Days)
Adverse Event
|
1
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
All Participants
n=16 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.
|
|---|---|
|
Age, Continuous
|
42.00 Years
STANDARD_DEVIATION 11.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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 7Population: 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.
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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Area Under the Concentration-Time Curve From Time Zero (0) Extrapolated to Infinity (AUCinf) of Total Dabigatran in Period 1, 4 and 7
|
1359 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 43
|
1195 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 38
|
1141 nanogram*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 92
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 7Population: 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.
AUClast was determined using the linear/log trapezoidal method.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
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
|
1154 ng*hr/mL
Geometric Coefficient of Variation 39
|
1089 ng*hr/mL
Geometric Coefficient of Variation 97
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 8Population: PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 2, 5 and 8 only.
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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=12 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=14 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=13 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
AUCinf of Rosuvastatin in Period 2, 5 and 8
|
26.86 ng*hr/mL
Geometric Coefficient of Variation 36
|
67.79 ng*hr/mL
Geometric Coefficient of Variation 58
|
63.83 ng*hr/mL
Geometric Coefficient of Variation 60
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 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 8Population: PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 2, 5 and 8 only.
AUClast was determined using the linear/log trapezoidal method.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
AUClast of Rosuvastatin in Period 2, 5 and 8
|
29.69 ng*hr/mL
Geometric Coefficient of Variation 47
|
63.30 ng*hr/mL
Geometric Coefficient of Variation 58
|
69.03 ng*hr/mL
Geometric Coefficient of Variation 68
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
n=15 Participants
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
n=15 Participants
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
n=15 Participants
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)- All Causalities
|
0 Participants
|
0 Participants
|
6 Participants
|
15 Participants
|
6 Participants
|
15 Participants
|
4 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=3 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
n=15 Participants
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
n=15 Participants
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
15 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
n=1 Participants
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
n=15 Participants
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
n=15 Participants
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Percent Change From Baseline in Body Weight
Day 12 of Period 6
|
-4.82 Percent change
Standard Deviation 2.276
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Body Weight
Day 1 of Period 8
|
-6.52 Percent change
Standard Deviation 3.272
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Body Weight
Day 5 of Period 8
|
-6.90 Percent change
Standard Deviation 2.778
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Body Weight
Day 1 of Period 3
|
-0.51 Percent change
Standard Deviation 0.950
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Body Weight
Day 8 of Period 3
|
-1.02 Percent change
Standard Deviation 1.559
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Body Weight
Day 1 of Period 5
|
-2.58 Percent change
Standard Deviation 2.146
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Body Weight
Day 5 of Period 6
|
-3.32 Percent change
Standard Deviation 2.170
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent Change From Baseline in Body Weight
Follow-up
|
-6.01 Percent change
Standard Deviation 3.327
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=1 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
n=15 Participants
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Pre-defined Criteria of Electrocardiogram (ECG) Parameters
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Day -1 of Period 1 (Completed suicide)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Day -1 of Period 1 (Suicide attempt)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Day -1 of Period 1 (Suicidal ideation)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Day 8 of Period 3 (Completed suicide)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Day 8 of Period 3 (Suicide attempt)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Day 8 of Period 3 (Suicidal ideation)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Day 5 of Period 6 (Completed suicide)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Day 5 of Period 6 (Suicide attempt)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Day 5 of Period 6 (Suicidal ideation)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Day 5 of Period 8 (Completed suicide)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Day 5 of Period 8 (Suicide attempt)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Day 5 of Period 8 (Suicidal ideation)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Follow-up (Completed suicide)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Follow-up (Suicide attempt)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Follow-up (Preparatory acts towards imminent suicidal behavior)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Follow-up (Suicidal ideation)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Columbia-Suicide Severity Rating Scale (C-SSRS)
Follow-up (Self-injurious behavior, no suicidal intent)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 interventionPopulation: 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.
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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Poor appetite or overeating · Not at all
|
11 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-Up: Little interest/pleasure in things · Not at all
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-Up: Little interest/pleasure in things · Several days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-Up: Little interest/pleasure in things · Nearly every day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Feeling down depressed or hopeless · Not at all
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Feeling down depressed or hopeless · Several days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Feeling down depressed or hopeless · Nearly every day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Trouble falling or staying asleep · Not at all
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Trouble falling or staying asleep · Several days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Trouble falling or staying asleep · Nearly every day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Feeling tired or little energy · Not at all
|
15 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Feeling tired or little energy · Several days
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Feeling tired or little energy · Nearly every day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Poor appetite or overeating · Several days
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Poor appetite or overeating · Nearly every day
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Feeling bad about yourself · Not at all
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Feeling bad about yourself · Several days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Feeling bad about yourself · Nearly every day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Trouble concentrating on things · Not at all
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Trouble concentrating on things · Several days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Trouble concentrating on things · Nearly every day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Moving slowly or fidgety/restless · Not at all
|
16 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Moving slowly or fidgety/restless · Several days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Moving slowly or fidgety/restless · Nearly every day
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants According to Patient Health Questionnaire-9 (PHQ-9) Classification
Follow-up: Thoughts you be better off dead · Several days
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
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
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 7Population: 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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Maximum Observed Concentration (Cmax) of Total Dabigatran in Period 1, 4 and 7
|
186.0 ng/mL
Geometric Coefficient of Variation 54
|
86.01 ng/mL
Geometric Coefficient of Variation 48
|
90.18 ng/mL
Geometric Coefficient of Variation 104
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 7Population: 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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Time for Cmax (Tmax) of Total Dabigatran in Period 1, 4 and 7
|
3.00 Hours
Interval 2.0 to 4.0
|
6.00 Hours
Interval 2.0 to 12.0
|
6.00 Hours
Interval 3.0 to 8.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 7Population: 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.
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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Terminal Half-Life (t1/2) of Total Dabigatran in Period 1, 4 and 7
|
8.921 Hours
Standard Deviation 2.8387
|
9.023 Hours
Standard Deviation 1.3586
|
9.208 Hours
Standard Deviation 2.0514
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 7Population: 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.
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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Volume of Distribution (Vz/F) of Total Dabigatran in Period 1, 4 and 7
|
1374 Liters
Geometric Coefficient of Variation 53
|
1618 Liters
Geometric Coefficient of Variation 48
|
1707 Liters
Geometric Coefficient of Variation 89
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 7Population: 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.
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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Apparent Oral Clearance (CL/F) of Total Dabigatran in Period 1, 4 and 7
|
110.3 Liters/Hours
Geometric Coefficient of Variation 43
|
125.6 Liters/Hours
Geometric Coefficient of Variation 38
|
131.5 Liters/Hours
Geometric Coefficient of Variation 92
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 8Population: PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 2, 5 and 8 only.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Cmax of Rosuvastatin in Period 2, 5 and 8
|
2.230 ng/mL
Geometric Coefficient of Variation 63
|
3.951 ng/mL
Geometric Coefficient of Variation 70
|
4.964 ng/mL
Geometric Coefficient of Variation 88
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 8Population: PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 2, 5 and 8 only.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=16 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Tmax of Rosuvastatin in Period 2, 5 and 8
|
5.00 Hours
Interval 4.0 to 5.0
|
5.00 Hours
Interval 3.0 to 10.0
|
5.00 Hours
Interval 3.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 8Population: PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 2, 5 and 8 only.
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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=12 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=14 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=13 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
t1/2 of Rosuvastatin in Period 2, 5 and 8
|
25.40 Hours
Standard Deviation 9.2472
|
25.52 Hours
Standard Deviation 16.897
|
19.06 Hours
Standard Deviation 5.0112
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 8Population: PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 2, 5 and 8 only.
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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=12 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=14 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=13 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Vz/F of Rosuvastatin in Period 2, 5 and 8
|
12900 Liters
Geometric Coefficient of Variation 45
|
4753 Liters
Geometric Coefficient of Variation 88
|
4171 Liters
Geometric Coefficient of Variation 63
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 8Population: PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 2, 5 and 8 only.
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.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=12 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=14 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=13 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
CL/F of Rosuvastatin in Period 2, 5 and 8
|
372.5 Liters/Hours
Geometric Coefficient of Variation 36
|
147.4 Liters/Hours
Geometric Coefficient of Variation 58
|
156.5 Liters/Hours
Geometric Coefficient of Variation 60
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 8Population: PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 4 and 8 only.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=14 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
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
|
701300 ng*hr/mL
Geometric Coefficient of Variation 53
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 8Population: PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 4 and 8 only.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=14 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
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
|
42730 ng/mL
Geometric Coefficient of Variation 43
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 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 8Population: PK parameter set included all participants who received at least 1 dose of rosuvastatin, dabigatran etexilate, and/or PF-07081532 and had at least 1 of the PK parameters of interest calculated. Here, "Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure. Data for this outcome measure was planned to be collected for Period 4 and 8 only.
Outcome measures
| Measure |
Period 1: DE 150 mg
n=15 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=14 Participants
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Tmax of PF-07081532 When Co-administered With DE and ROSU in Period 4 and 8 Respectively
|
6.00 Hours
Interval 1.0 to 8.0
|
4.00 Hours
Interval 2.0 to 10.0
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Period 1: DE 150 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Period 2: ROSU 10 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Period 3: PF-07081532 40 mg QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Period 4: DE 150 mg + PF-07081532 80 mg QD
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Period 5: ROSU 10mg + PF-07081532 80 mg QD
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Period 6: PF-07081532 240 mg QD
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Period 7: PF-07081532 240 mg QD + DE 150 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Period 1: DE 150 mg
n=16 participants at risk
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 2: ROSU 10 mg
n=16 participants at risk
Participants received ROSU 10 mg as single dose on Day 1 of Period 2.
|
Period 3: PF-07081532 40 mg QD
n=16 participants at risk
Participants received oral PF-07081532 titrated from 20 mg up to 40 mg QD for 8 days in Period 3.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=16 participants at risk
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
n=15 participants at risk
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
n=15 participants at risk
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=15 participants at risk
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
n=15 participants at risk
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.7%
1/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
Other adverse events
| Measure |
Period 1: DE 150 mg
n=16 participants at risk
Participants received DE 150 mg as single oral dose on Day 1 of Period 1.
|
Period 2: ROSU 10 mg
n=16 participants at risk
Participants received ROSU 10 mg as single dose on Day 1 of Period 2.
|
Period 3: PF-07081532 40 mg QD
n=16 participants at risk
Participants received oral PF-07081532 titrated from 20 mg up to 40 mg QD for 8 days in Period 3.
|
Period 4: DE 150 mg + PF-07081532 80 mg QD
n=16 participants at risk
Participants received DE 150 mg as single oral dose on Day 1 of Period 4 and PF-07081532 80 mg QD orally from Day 1 to 5 in Period 4.
|
Period 5: ROSU 10mg + PF-07081532 80 mg QD
n=15 participants at risk
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 5 and PF-07081532 80 mg QD orally from Day 1 to 4 in Period 5.
|
Period 6: PF-07081532 240 mg QD
n=15 participants at risk
Participants received oral PF-07081532 titrated from 20 mg up to 240 mg QD for 17 days in Period 6.
|
Period 7: PF-07081532 240 mg QD + DE 150 mg
n=15 participants at risk
Participants received DE 150 mg as single oral dose on Day 1 of Period 7 and PF-07081532 240 mg QD orally from Day 1 to 2 in Period 7.
|
Period 8: PF-07081532 240 mg QD + ROSU 10 mg
n=15 participants at risk
Participants received ROSU 10 mg as single oral dose on Day 1 of Period 8 and PF-07081532 240 mg QD orally from Day 1 to 4 in Period 8.
|
|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.2%
1/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.2%
1/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
2/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
13.3%
2/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
40.0%
6/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
43.8%
7/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
26.7%
4/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
13.3%
2/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
25.0%
4/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
43.8%
7/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
20.0%
3/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.7%
1/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
18.8%
3/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.7%
1/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
13.3%
2/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.2%
1/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
40.0%
6/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.2%
1/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
31.2%
5/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
26.7%
4/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
13.3%
2/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
37.5%
6/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
13.3%
2/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
33.3%
5/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
13.3%
2/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
20.0%
3/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
General disorders
Early satiety
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
18.8%
3/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.7%
1/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
13.3%
2/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
12.5%
2/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
25.0%
4/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.7%
1/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.2%
1/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.7%
1/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
13.3%
2/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
20.0%
3/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.7%
1/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
26.7%
4/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.2%
1/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/16 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
6.7%
1/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
0.00%
0/15 • From first dose of study drug up to 28-35 days post last dose of study intervention (maximum up to 76-83 days)
Safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER