Trial Outcomes & Findings for A Drug-Drug Interaction Study Between PF-06882961 and PF-06865571 in Healthy Adult Participants and Overweight Adults or Adults With Obesity Who Are Otherwise Healthy (NCT NCT04839393)
NCT ID: NCT04839393
Last Updated: 2023-08-21
Results Overview
AUCinf for PF-06865571 was calculated as AUClast + (Clast\*/kel) on Day 1 and Day 47. Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the elimination rate constant.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 and 48 hours post-dose
Results posted on
2023-08-21
Participant Flow
A total of 8 participants were enrolled in Part A of the study and 19 participants were enrolled in Part B of the study.
Part A of the study was an open-label, 2-period, 2-sequence, crossover study. Part B of the study was an open-label, fixed-sequence study.
Participant milestones
| Measure |
Part A Sequence 1
There were 2 periods in Part A. Participants assigned to Sequence 1 received a single dose of PF-06882961 20 mg in Period 1, after a washout of at least 3 days, participants received a single dose of PF-06882961 20 mg + PF-06865571 300 mg in Period 2.
|
Part A Sequence 2
There were 2 periods in Part A. Participants assigned to Sequence 2 received a single dose of PF-06882961 20 mg + PF-06865571 300 mg in Period 1, after a washout of at least 3 days, participants received a single dose of PF-06882961 20 mg in Period 2.
|
Part B
There were 4 periods in Part B. All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4 (Days 49-62), participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
19
|
|
Overall Study
Received Treatment
|
4
|
4
|
19
|
|
Overall Study
COMPLETED
|
4
|
4
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
3
|
Reasons for withdrawal
| Measure |
Part A Sequence 1
There were 2 periods in Part A. Participants assigned to Sequence 1 received a single dose of PF-06882961 20 mg in Period 1, after a washout of at least 3 days, participants received a single dose of PF-06882961 20 mg + PF-06865571 300 mg in Period 2.
|
Part A Sequence 2
There were 2 periods in Part A. Participants assigned to Sequence 2 received a single dose of PF-06882961 20 mg + PF-06865571 300 mg in Period 1, after a washout of at least 3 days, participants received a single dose of PF-06882961 20 mg in Period 2.
|
Part B
There were 4 periods in Part B. All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4 (Days 49-62), participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by participant
|
0
|
0
|
1
|
Baseline Characteristics
A Drug-Drug Interaction Study Between PF-06882961 and PF-06865571 in Healthy Adult Participants and Overweight Adults or Adults With Obesity Who Are Otherwise Healthy
Baseline characteristics by cohort
| Measure |
Part A Sequence 1
n=4 Participants
There were 2 periods in Part A. Participants assigned to Sequence 1 received a single dose of PF-06882961 20 mg in Period 1, after a washout of at least 3 days, participants received a single dose of PF-06882961 20 mg + PF-06865571 300 mg in Period 2.
|
Part A Sequence 2
n=4 Participants
There were 2 periods in Part A. Participants assigned to Sequence 2 received a single dose of PF-06882961 20 mg + PF-06865571 300 mg in Period 1, after a washout of at least 3 days, participants received a single dose of PF-06882961 20 mg in Period 2.
|
Part B
n=19 Participants
There were 4 periods in Part B. All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4 (Days 49-62), participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
18-44 Years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Age, Customized
45-64 Years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Age, Customized
>=65 Years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1Population: The PK concentration analysis set for PF-06882961 included all randomized participants who received at least 1 dose of PF-06882961 and in whom at least 1 plasma concentration value was reported.
Cmax for PF-06882961 was observed directly from data.
Outcome measures
| Measure |
PF-06882961 20 mg
n=8 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=8 Participants
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Part A: PF-06882961 Maximum Observed Concentration (Cmax)
|
15.69 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 198
|
17.09 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 265
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 1Population: The PK parameter analysis set for PF-06882961 included all randomized participants who received at least 1 dose of PF-06882961 and in whom at least 1 parameter value was reported.
AUC24 for PF-06882961 was determined by Linear/Log trapezoidal method.
Outcome measures
| Measure |
PF-06882961 20 mg
n=8 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=8 Participants
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Part A: PF-06882961 Area Under the Plasma Concentration-time Profile From Time 0 to the Time 24 Hours Post-dose (AUC24)
|
109.5 nanogram*hour per milliliter (ng.hr/mL)
Geometric Coefficient of Variation 198
|
123.9 nanogram*hour per milliliter (ng.hr/mL)
Geometric Coefficient of Variation 311
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 and 48 hours post-dosePopulation: The PK concentration analysis set for PF-06865571 included all randomized participants who received at least 1 dose of PF-06865571 and in whom at least 1 plasma concentration value is reported.
Cmax for PF-06865571 was observed directly from data on Day 1 and Day 47.
Outcome measures
| Measure |
PF-06882961 20 mg
n=19 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=16 Participants
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Part B: PF-06865571 Cmax on Day 1 and Day 47
|
2078 ng/mL
Geometric Coefficient of Variation 37
|
791 ng/mL
Geometric Coefficient of Variation 41
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 and 48 hours post-dosePopulation: The PK parameter analysis set for PF-06865571 included all randomized participants who received at least 1 dose of PF-06865571 and in whom at least 1 parameter value was reported.
AUClast for PF-06865571 was determined by Linear/Log trapezoidal method on Day 1 and Day 47.
Outcome measures
| Measure |
PF-06882961 20 mg
n=19 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=16 Participants
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Part B: PF-06865571 Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) on Day 1 and Day 47
|
9011 ng*hr/mL
Geometric Coefficient of Variation 38
|
6630 ng*hr/mL
Geometric Coefficient of Variation 40
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 24 and 48 hours post-dosePopulation: The PK parameter analysis set for PF-06865571 included all randomized participants who received at least 1 dose of PF-06865571 and in whom at least 1 parameter value was reported.
AUCinf for PF-06865571 was calculated as AUClast + (Clast\*/kel) on Day 1 and Day 47. Clast\* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis and kel was the elimination rate constant.
Outcome measures
| Measure |
PF-06882961 20 mg
n=19 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=14 Participants
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Part B: PF-06865571 Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) on Day 1 and Day 47
|
9029 ng*hr/mL
Geometric Coefficient of Variation 38
|
6726 ng*hr/mL
Geometric Coefficient of Variation 43
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dosePopulation: The PK parameter analysis set for PF-06882961 included all randomized participants who received at least 1 dose of PF-06882961 and in whom at least 1 parameter value was reported.
Cmax for PF-06882961 was observed directly from data on Day 46 and Day 61.
Outcome measures
| Measure |
PF-06882961 20 mg
n=15 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=14 Participants
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Part B: PF-06882961 Cmax on Day 46 and Day 61
|
1187 ng/mL
Geometric Coefficient of Variation 115
|
1393 ng/mL
Geometric Coefficient of Variation 107
|
—
|
—
|
PRIMARY outcome
Timeframe: 0 (prior to dosing), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dosePopulation: The PK parameter analysis set for PF-06882961 included all randomized participants who received at least 1 dose of PF-06882961 and in whom at least 1 parameter value was reported.
AUC 12 for PF-06882961 was determined by Linear/Log trapezoidal method on Day 46 and Day 61.
Outcome measures
| Measure |
PF-06882961 20 mg
n=15 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=14 Participants
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Part B: PF-06882961 Area Under the Plasma Concentration-time Profile From Time 0 to the Time 12 Hours Post-dose (AUC12) on Day 46 and Day 61
|
7682 ng.hr/mL
Geometric Coefficient of Variation 99
|
9312 ng.hr/mL
Geometric Coefficient of Variation 99
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 68 daysPopulation: The safety analysis set included all participants randomly assigned to investigational product and who took at least 1 dose of study intervention.
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any AEs occurring following start of study intervention were counted as treatment emergent. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Relatedness to study treatment was determined by the investigator.
Outcome measures
| Measure |
PF-06882961 20 mg
n=8 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=8 Participants
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) in Part A
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Screening (28 days prior to the day of treatment) to Day 2 of Period 2, for a maximum of 33 DaysPopulation: The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable laboratory values were analyzed.
Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion. Abnormalities without regard to baseline abnormalities were reported.
Outcome measures
| Measure |
PF-06882961 20 mg
n=8 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=8 Participants
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities in Part A
|
2 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Screening (28 days prior to the day of treatment) to Day 2 of Period 2, for a maximum of 33 DaysPopulation: The safety analysis set included all participants randomly assigned to investigational product and who took at least 1 dose of study intervention. Participants with evaluable vital signs data were analyzed.
Single, supine vital signs assessments included systolic blood pressure (BP), diastolic BP and pulse rate. Abnormality in vital signs included: pulse rate \<40 beats per minute (bpm) or \>120bpm; supine diastolic BP \<50 millimeter of mercury (mmHg), increase and decrease in change from baseline (BL) of \>=20mmHg; supine systolic blood pressure \<90mmHg, increase and decrease in change from BL of \>=30mmHg.
Outcome measures
| Measure |
PF-06882961 20 mg
n=8 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=8 Participants
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part A
Supine systolic BP value <90mmHg
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part A
Supine systolic BP change >=30mmHg increase
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part A
Supine systolic BP change >=30mmHg decrease
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part A
Supine diastolic BP value <50mmHg
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part A
Supine diastolic BP change >=20mmHg increase
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part A
Supine diastolic BP change >=20mmHg decrease
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part A
Pulse rate value <40bpm
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part A
Pulse rate value >120bpm
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From Screening (28 days prior to the day of treatment) to Day 2 of Period 2, for a maximum of 33 DaysPopulation: The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable ECG data were analyzed.
ECG assessments included pulse rate (PR), QT, QTcF intervals and QRS complex. ECG abnormalities criteria included: PR interval value \>= 300msec, or baseline (BL) \>200msec and \>=25% increase from BL, or BL \<=200msec and \>=50% increase from BL; QRS interval value \>= 140msec, or percent change from BL \>=50%; QTcF value \>400 and \<=480msec, or \>480 and \<=500 msec, or \>500msec, or change from BL\>30 and \<=60msec, or change from BL \>60msec.
Outcome measures
| Measure |
PF-06882961 20 mg
n=8 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=8 Participants
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria in Part A
PR interval value >= 300 msec
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria in Part A
PR interval %change >=25/50% (BL >200 msec and >=25% increase or BL <=200 msec and >=50% increase)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria in Part A
QRS interval value>=140 msec
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria in Part A
QRS interval %change >=50%
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria in Part A
QTcF value >450 and <=480 msec
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria in Part A
QTcF value >480 and <=500 msec
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria in Part A
QTcF value >500 msec
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria in Part A
QTcF change >30 and <=60 msec
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-specified Criteria in Part A
QTcF change >60 msec
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 173 daysPopulation: The safety analysis set included all participants randomly assigned to investigational product and who took at least 1 dose of study intervention.
An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Any AEs occurring following start of study intervention were counted as treatment emergent. Serious AEs (SAEs) were defined as any untoward medical occurrence at any dose that resulted in death; was life-threatening (immediate risk of death); required inpatient hospitalization or caused prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduction normal life functions). AEs included SAEs and non-serious AEs. Relatedness to study treatment was determined by the investigator.
Outcome measures
| Measure |
PF-06882961 20 mg
n=19 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=19 Participants
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
n=16 Participants
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
n=16 Participants
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Number of Participants With TEAEs in Part B
All-causality TEAEs
|
1 Participants
|
18 Participants
|
6 Participants
|
10 Participants
|
|
Number of Participants With TEAEs in Part B
Treatment-related TEAEs
|
1 Participants
|
16 Participants
|
6 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: From Screening (28 days prior to follow-up visit (up to 10 days after the last dose of treatment), for a maximum of 148 DaysPopulation: The safety analysis set included all participants randomly assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable laboratory values were analyzed.
Safety laboratory assessments included clinical chemistry, hematology, urinalysis, and other tests. Abnormality was determined at the investigator's discretion. Abnormalities without regard to baseline abnormalities were reported.
Outcome measures
| Measure |
PF-06882961 20 mg
n=19 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=19 Participants
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
n=16 Participants
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
n=16 Participants
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Number of Participants With Clinical Laboratory Abnormalities in Part B
|
0 Participants
|
16 Participants
|
0 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: From Screening (28 days prior to follow-up visit (up to 10 days after the last dose of treatment), for a maximum of 148 DaysPopulation: The safety analysis set included all participants randomly assigned to investigational product and who took at least 1 dose of study intervention. Participants with evaluable vital signs data were analyzed.
Single, supine vital signs assessments included systolic blood pressure (BP), diastolic BP and pulse rate. Abnormality in vital signs included: pulse rate \<40 beats per minute (bpm) or \>120bpm; supine diastolic BP \<50 millimeter of mercury (mmHg), increase and decrease in change from BL of \>=20mmHg; supine systolic blood pressure \<90mmHg, increase and decrease in change from BL of \>=30mmHg.
Outcome measures
| Measure |
PF-06882961 20 mg
n=19 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=19 Participants
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
n=16 Participants
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
n=16 Participants
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part B
Supine systolic BP value <90mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part B
Supine systolic BP change >=30mmHg increase
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part B
Supine systolic BP change >=30mmHg decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part B
Supine diastolic BP value <50mmHg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part B
Supine diastolic BP change >=20mmHg increase
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part B
Supine diastolic BP change >=20mmHg decrease
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part B
Pulse rate value <40bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Vital Signs Data Meeting Pre-specified Criteria in Part B
Pulse rate value >120bpm
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Baseline (Days -28 to 2), on Period 2, Days 6, 13, 20 ,27, 34, and 41, Period 4, Days 9 and14 and follow-up visit (Days 68-71)Population: The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable body weight data were analyzed.
Changes from baseline in body weight of the participants were measured.
Outcome measures
| Measure |
PF-06882961 20 mg
n=19 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Change From Baseline in Body Weight for Participants in Part B
Period 2 Day 6
|
-0.73 kilogram (kg)
Standard Deviation 1.999
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight for Participants in Part B
Period 2 Day 13
|
-1.49 kilogram (kg)
Standard Deviation 2.260
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight for Participants in Part B
Period 2 Day 20
|
-2.48 kilogram (kg)
Standard Deviation 2.242
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight for Participants in Part B
Period 2 Day 27
|
-3.32 kilogram (kg)
Standard Deviation 2.525
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight for Participants in Part B
Period 2 Day 34
|
-4.76 kilogram (kg)
Standard Deviation 3.141
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight for Participants in Part B
Period 2 Day 41
|
-5.39 kilogram (kg)
Standard Deviation 2.599
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight for Participants in Part B
Period 4 Day 2
|
-6.09 kilogram (kg)
Standard Deviation 3.088
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight for Participants in Part B
Period 4 Day 9
|
-6.89 kilogram (kg)
Standard Deviation 3.299
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight for Participants in Part B
Period 4 Day 14
|
-6.93 kilogram (kg)
Standard Deviation 3.632
|
—
|
—
|
—
|
|
Change From Baseline in Body Weight for Participants in Part B
Follow-up
|
-4.59 kilogram (kg)
Standard Deviation 3.916
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From Screening (28 days prior to follow-up visit (up to 10 days after the last dose of treatment), for a maximum of 148 DaysPopulation: The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable ECG data were analyzed.
ECG assessments included PR, QT, QTcF intervals and QRS complex. ECG abnormalities criteria included: PR interval value \>= 300msec, or BL \>200msec and \>=25% increase from BL, or BL \<=200msec and \>=50% increase from BL; QRS interval value \>= 140msec, or percent change from BL \>=50%; QTcF value \>400 and \<=480msec, or \>480 and \<=500 msec, or \>500msec, or change from BL\>30 and \<=60msec, or change from BL \>60msec.
Outcome measures
| Measure |
PF-06882961 20 mg
n=19 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=16 Participants
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Number of Participants With ECG Data Meeting Pre-specified Criteria in Part B
PR interval value>=300 msec
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-specified Criteria in Part B
PR interval %change >=25/50% (BL >200 msec and >=25% increase or BL <=200 msec and >=50% increase)
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-specified Criteria in Part B
QRS interval value>=140 msec
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-specified Criteria in Part B
QRS interval %change >=50%
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-specified Criteria in Part B
QTcF value >450 and <=480 msec
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-specified Criteria in Part B
QTcF value >480 and <=500 msec
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-specified Criteria in Part B
QTcF value >500 msec
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-specified Criteria in Part B
QTcF change >30 and <=60 msec
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With ECG Data Meeting Pre-specified Criteria in Part B
QTcF change >60 msec
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: At Screening (Days -28 to -2), Baseline (Period 1 Day -1), on Period 2, Days 6, 13, 20, 27, 34 and 41, Period 4, Days 2, 9 and 14 and follow-up visit (Days 68-71)Population: The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable C-SSRS results were analyzed.
The C-SSRS was an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced any of the following 1: completed suicide, 2: suicide attempt (response of "yes" on "actual attempt"), 3: preparatory acts toward imminent suicidal behavior ("yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), 4: any suicidal behavior or ideation, suicidal ideation ("yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent"), 7: self-injurious behavior, no suicidal intent ("yes" on "has participant engaged in non-suicidal self-injurious behavior").
Outcome measures
| Measure |
PF-06882961 20 mg
n=19 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Number of Participants With Suicidal Ideation or Behavior as Per C-SSRS Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) in Part B
Baseline
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation or Behavior as Per C-SSRS Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) in Part B
Period 2 Day 6
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation or Behavior as Per C-SSRS Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) in Part B
Period 2 Day 13
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation or Behavior as Per C-SSRS Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) in Part B
Period 2 Day 20
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation or Behavior as Per C-SSRS Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) in Part B
Period 2 Day 27
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation or Behavior as Per C-SSRS Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) in Part B
Period 2 Day 34
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation or Behavior as Per C-SSRS Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) in Part B
Period 2 Day 41
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation or Behavior as Per C-SSRS Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) in Part B
Period 4 Day 2
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation or Behavior as Per C-SSRS Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) in Part B
Period 4 Day 9
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation or Behavior as Per C-SSRS Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) in Part B
Period 4 Day 14
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Suicidal Ideation or Behavior as Per C-SSRS Mapped to Columbia Classification Algorithm of Suicide Assessment (C-CASA) in Part B
Follow-up
|
0 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Screening (Days -28 to -2), Baseline (Period 1 Day -1), on Period 2, Days 6, 13, 20, 27, 34 and 41, Period 4, Days 2, 9 and 14 and follow-up visit (Days 68-71)Population: The analysis set included all participants assigned to study intervention and who took at least 1 dose of study intervention. Participants with evaluable PHQ-9 results were analyzed.
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", "several days", "more than half the days" to "nearly every day". Total score range: 0-27 (each item with scale from 0 \[not at all\] to 3 \[nearly every day\]. Higher score=greater severity). Any participant with a response of any scale other than "not at all" to any of the 9 questions was counted.
Outcome measures
| Measure |
PF-06882961 20 mg
n=19 Participants
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
Participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
All participants in Part B received a single dose of PF-06865571 300 mg on Day 1 Period 1 (Days 1-2) , and PF-06882961 10 mg twice daily (BID) titrated to 200 mg BID in Period 2 (Days 3-46). In Period 3 (Days 47-48), participants received a single dose of PF-06865571 300 mg on Day 47 only and PF-06882961 200 mg BID. In Period 4, participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID on Days 49-61.
|
|---|---|---|---|---|
|
Number of Participants With Response to PHQ-9 in Part B
Baseline
|
2 Participants
|
—
|
—
|
—
|
|
Number of Participants With Response to PHQ-9 in Part B
Period 2 Day 6
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Response to PHQ-9 in Part B
Period 2 Day 13
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Response to PHQ-9 in Part B
Period 2 Day 20
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Response to PHQ-9 in Part B
Period 2 Day 27
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Response to PHQ-9 in Part B
Period 2 Day 34
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Response to PHQ-9 in Part B
Period 2 Day 41
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Response to PHQ-9 in Part B
Period 4 Day 2
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Response to PHQ-9 in Part B
Period 4 Day 9
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Response to PHQ-9 in Part B
Period 4 Day 14
|
0 Participants
|
—
|
—
|
—
|
|
Number of Participants With Response to PHQ-9 in Part B
Follow-up
|
0 Participants
|
—
|
—
|
—
|
Adverse Events
PF-06882961 20 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PF-06882961 20 mg + PF-06865571 300 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
PF-06865571 300 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
PF-06882961 Titration up to 200 mg BID
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
PF-06865571 300 mg + PF-06882961 200 mg BID
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
PF-06865571 300 mg BID + PF-06882961 200 mg BID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-06882961 20 mg
n=8 participants at risk
Participants received PF-06882961 20 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06882961 20 mg + PF-06865571 300 mg
n=8 participants at risk
In Part A, participants received PF-06882961 20 mg + PF-06865571 300 mg on Day 1 in either Period 1 or 2, depending on the treatment sequence they were assigned to.
|
PF-06865571 300 mg
n=19 participants at risk
Participants received a single dose of PF-06865571 300 mg on Day 1 in Part B Period 1 (Days 1-2).
|
PF-06882961 Titration up to 200 mg BID
n=19 participants at risk
Participants received PF-06882961 titrated up to 200 mg BID in Part B Period 2 (Days 3-46).
|
PF-06865571 300 mg + PF-06882961 200 mg BID
n=16 participants at risk
Participants received PF-06865571 300 mg single dose on Day 47 and PF-06882961 200 mg BID in Period 3 (Days 47-48).
|
PF-06865571 300 mg BID + PF-06882961 200 mg BID
n=16 participants at risk
Participants received PF-06865571 300 mg BID and PF-06882961 200 mg BID in on Days 49-61 in Period 4.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
15.8%
3/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
6.2%
1/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
12.5%
2/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
15.8%
3/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
6.2%
1/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
31.6%
6/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
6.2%
1/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
15.8%
3/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
6.2%
1/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
42.1%
8/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
12.5%
2/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
5.3%
1/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
63.2%
12/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
6.2%
1/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
37.5%
6/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
36.8%
7/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
18.8%
3/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
37.5%
6/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
General disorders
Fatigue
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
5.3%
1/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
General disorders
Peripheral swelling
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
6.2%
1/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
12.5%
2/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
12.5%
2/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
15.8%
3/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
52.6%
10/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
6.2%
1/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
5.3%
1/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
10.5%
2/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
12.5%
2/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
21.1%
4/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
6.2%
1/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
25.0%
4/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
10.5%
2/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
42.1%
8/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
6.2%
1/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/8 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/19 • Up to 68 days for Part A and up to 173 days for Part B.
|
0.00%
0/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
6.2%
1/16 • Up to 68 days for Part A and up to 173 days for Part B.
|
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