Trial Outcomes & Findings for A Study To Evaluate The Safety And Effects On The Body Of An Investigational Drug Using An Endotoxin-Induced Inflammatory Response Model (NCT NCT01965600)
NCT ID: NCT01965600
Last Updated: 2016-08-02
Results Overview
MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.
Recruitment status
TERMINATED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Days 1, 3-5
Results posted on
2016-08-02
Participant Flow
Participant milestones
| Measure |
PF-06282999 125 mg TID Followed by Placebo
Participants received PF-06282999 125 milligrams (mg) three times daily (TID) orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm). On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3. After about 15 days of washout, participants returned for the second period where they received placebo in the same manner as active treatment before.
|
Placebo Followed by PF-06282999 125 mg TID
Participants received placebo orally via tablets. Placebo matching PF-06282999 125 mg TID were administered on Days 1-3 at approximately 8am, 2pm, and 8pm. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3. Following a washout of about 15 days, participants returned for the second period where they received PF-06282999 125 mg TID in the same manner as placebo in the first period.
|
PF-06282999 500 mg BID Followed by Placebo
Participants received PF-06282999 500 milligrams (mg) twice daily (BID) orally in tablet form from Days 1 to 3 (8am and 8pm). On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3. After about 15 days of washout, participants returned for the second period where they received placebo in the same manner as active treatment before.
|
Placebo Followed by PF-06282999 500 mg BID
Participants received placebo orally via tablets. Placebo matching PF-06282999 500 mg BID were administered on Days 1-3 at 8am and 8pm. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3. Following a washout of about 15 days, participants returned for the second period where they received PF-06282999 500 mg BID in the same manner as placebo in the first period.
|
|---|---|---|---|---|
|
First Intervention
STARTED
|
6
|
8
|
5
|
4
|
|
First Intervention
Received at Least One Dose of Drug
|
6
|
8
|
5
|
4
|
|
First Intervention
COMPLETED
|
6
|
8
|
5
|
4
|
|
First Intervention
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout Period of Approximately 15 Days
STARTED
|
6
|
8
|
5
|
4
|
|
Washout Period of Approximately 15 Days
COMPLETED
|
4
|
4
|
3
|
2
|
|
Washout Period of Approximately 15 Days
NOT COMPLETED
|
2
|
4
|
2
|
2
|
|
Second Intervention
STARTED
|
4
|
4
|
3
|
2
|
|
Second Intervention
COMPLETED
|
4
|
4
|
1
|
0
|
|
Second Intervention
NOT COMPLETED
|
0
|
0
|
2
|
2
|
Reasons for withdrawal
| Measure |
PF-06282999 125 mg TID Followed by Placebo
Participants received PF-06282999 125 milligrams (mg) three times daily (TID) orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm). On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3. After about 15 days of washout, participants returned for the second period where they received placebo in the same manner as active treatment before.
|
Placebo Followed by PF-06282999 125 mg TID
Participants received placebo orally via tablets. Placebo matching PF-06282999 125 mg TID were administered on Days 1-3 at approximately 8am, 2pm, and 8pm. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3. Following a washout of about 15 days, participants returned for the second period where they received PF-06282999 125 mg TID in the same manner as placebo in the first period.
|
PF-06282999 500 mg BID Followed by Placebo
Participants received PF-06282999 500 milligrams (mg) twice daily (BID) orally in tablet form from Days 1 to 3 (8am and 8pm). On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3. After about 15 days of washout, participants returned for the second period where they received placebo in the same manner as active treatment before.
|
Placebo Followed by PF-06282999 500 mg BID
Participants received placebo orally via tablets. Placebo matching PF-06282999 500 mg BID were administered on Days 1-3 at 8am and 8pm. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3. Following a washout of about 15 days, participants returned for the second period where they received PF-06282999 500 mg BID in the same manner as placebo in the first period.
|
|---|---|---|---|---|
|
Washout Period of Approximately 15 Days
Study terminated by Sponsor
|
1
|
3
|
2
|
1
|
|
Washout Period of Approximately 15 Days
Withdrawal by Subject
|
0
|
1
|
0
|
0
|
|
Washout Period of Approximately 15 Days
Did not meet entrance criteria
|
1
|
0
|
0
|
0
|
|
Washout Period of Approximately 15 Days
Adverse Event
|
0
|
0
|
0
|
1
|
|
Second Intervention
Study terminated by Sponsor
|
0
|
0
|
2
|
2
|
Baseline Characteristics
A Study To Evaluate The Safety And Effects On The Body Of An Investigational Drug Using An Endotoxin-Induced Inflammatory Response Model
Baseline characteristics by cohort
| Measure |
All Participants
n=23 Participants
Participants received PF-06282999 125 mg TID or 500 mg BID or matching placebo orally in tablet form from Days 1 to 3. On Day 3, participants received a dose of LPS as an IV bolus at a dose of 4 ng/kg over 45-60 secs 2 hours after the morning dose of PF-06282999 or matching placebo. A final dose of PF-06282999 or matching placebo was administered on the evening of Day 3. Period 2 started after a washout period of approximately 15 days with at least 21 days in between administration of LPS. Participants who took active treatment (PF-06282999) in Period 1 received placebo in Period 2 and vice versa.
|
|---|---|
|
Age, Continuous
|
32.2 years
STANDARD_DEVIATION 5.3 • n=39 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Days 1, 3-5Population: Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.
MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Days 1, 3-5Population: Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.
MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Days 1, 3-5Population: Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.
MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: From Day 0 till approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2 (up to approximately 2 months)Population: All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.
An adverse event (AE) was any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as newly occurring AEs or those worsening after first dose. Due to early termination of the study, only AE data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.
Outcome measures
| Measure |
PF-06282999 125 mg TID
n=10 Participants
All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
|
Placebo
n=19 Participants
All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
|
PF-06282999 500 mg BID
n=7 Participants
All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
|
|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
Participants with TEAEs
|
10 participants
|
17 participants
|
5 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
Participants with SAEs
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Withdrawals Due to TEAEs
Participants discontinued permanently due to TEAEs
|
0 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to 7-10 days following the last dose of PF-06282999/Placebo in Period 2Population: All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.
Number of participants with laboratory test abnormalities without regard to baseline abnormality. Laboratory test parameters included hematology, coagulation, liver function, renal function, electrolytes, clinical chemistry, and urinalysis (dipstick and microscopy). Due to early termination of the study, only laboratory data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.
Outcome measures
| Measure |
PF-06282999 125 mg TID
n=10 Participants
All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
|
Placebo
n=19 Participants
All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
|
PF-06282999 500 mg BID
n=7 Participants
All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
|
|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
5 participants
|
8 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Screening and Days 1-2, 4-5, and approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2 for orthostatic (orth) measurements; Day 3 for supine measurementsPopulation: All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings. n=number of participants evaluable for that parameter
Categorical summarization criteria in vital signs included: sitting, supine, and standing systolic blood pressure (SBP) of less than (\<)90 millimeters of mercury (mm Hg) or change (increase \[inc\] or decrease \[dec\]) in sitting, supine and standing SBP of more than or equal to (\>=)30 mm Hg; supine, sitting, and standing diastolic blood pressure (DBP) of \<50 mm Hg or change (inc or dec) in sitting, supine, and standing DBP of \>=20 mm Hg; supine and sitting pulse rate (PR) of \<40 or more than (\>)120 beats per minute (bpm); and standing PR of \<40 or \>140 bpm. Due to early termination of the study, only vital signs data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.
Outcome measures
| Measure |
PF-06282999 125 mg TID
n=10 Participants
All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
|
Placebo
n=19 Participants
All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
|
PF-06282999 500 mg BID
n=7 Participants
All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
|
|---|---|---|---|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Orthostatic sitting SBP <90 mm Hg (n=1,0,0)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Orthostatic standing SBP <90 mm Hg (n=10,17,6)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Orthostatic supine DBP <50 mm Hg (n=10,18,7)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Orthostatic sitting DBP <50 mm Hg (n=1,0,0)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Orthostatic standing DBP <50 mm Hg (n=10,17,6)
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Orthostatic supine PR <40 bpm (n=10,18,7)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Orthostatic supine PR >120 bpm (n=10,18,7)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Orthostatic sitting PR <40 bpm (n=1,0,0)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Orthostatic standing PR <40 bpm (n=10,17,6)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Orthostatic standing PR >140 bpm (n=10,17,6)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Supine SBP <90 mm Hg (n=10,17,5)
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Supine DBP <50 mm Hg (n=10,17,5)
|
1 participants
|
2 participants
|
1 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Supine PR <40 bpm (n=10,17,5)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Supine PR >120 bpm (n=10,17,5)
|
1 participants
|
4 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Increase in orth supine SBP >=30 mm Hg (n=10,18,7)
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Inc in orth standing SBP >=30 mm Hg (n=10,17,6)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Inc in orth supine DBP >=20 mm Hg (n=10,18,7)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Inc in orth standing DBP >=20 mm Hg (n=10,17,6)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Inc in supine SBP >=30 mm Hg (n=10,17,5)
|
0 participants
|
4 participants
|
1 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Inc in supine DBP >=20 mm Hg (n=10,17,5)
|
1 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Dec in orth supine SBP >=30 mm Hg (n=10,18,7)
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Dec in orth standing SBP >=30 mm Hg (n=10,17,6)
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Dec in orth supine DBP >=20 mm Hg (n=10,18,7)
|
1 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Dec in orth standing DBP >=20 mm Hg (n=10,17,6)
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Dec in supine SBP >=30 mm Hg (n=10,17,5)
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Dec in supine DBP >=20 mm Hg (n=10,17,5)
|
1 participants
|
4 participants
|
2 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Orthostatic SBP <90 mm Hg (n=0,1,0)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Orthostatic DBP <50 mm Hg (n=0,1,0)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Orthostatic PR <40 bpm (n=0,1,0)
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Change From Baseline and Absolute Values in Vital Signs Meeting Categorical Summarization Criteria
Orthostatic supine SBP <90 mm Hg (n=10,18,7)
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Screening; Days 1-5 and approximately 7-10 days following the last dose of PF-06282999/Placebo in Period 2Population: All participants who received at least 1 dose of study medication (including LPS) were included in the safety analyses and listings.
Criteria for ECG (12-lead) values meeting categorical summarization criteria were: the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization (PR interval \>=300 milliseconds (msec) and increase from baseline \>=25/50%; time from the beginning of the ECG Q wave to the end of the S wave corresponding to ventricular depolarization (QRS) interval \>=140 msec and increase of \>=50%; the beginning of the Q wave to the end of the T wave corresponding to electrical systole (QT) interval \>=500 msec; QT corrected using the Fridericia formula (QTcF) of 450 to \<480 msec, 480 to \<500 msec, and \>=500 msec, or an increase of 30 to \<60 msec or \>=60 msec. Due to early termination of the study, only ECG data from partial enrollment are reflected and comparisons between treatment arms should not be attempted.
Outcome measures
| Measure |
PF-06282999 125 mg TID
n=10 Participants
All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
|
Placebo
n=19 Participants
All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
|
PF-06282999 500 mg BID
n=7 Participants
All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
|
|---|---|---|---|
|
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
PR interval >=300 msec
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
QRS >=140 msec
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
QT >=500 msec
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
QTcF 450 to <480 msec
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
QTcF 480 to <500 msec
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
QTcF >=500 msec
|
0 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
PR interval increase >=25/50%
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
QRS increase >=50%
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
QTcF increase 30 to <60 msec
|
0 participants
|
3 participants
|
1 participants
|
|
Number of Participants With Electrocardiogram (ECG) Values Meeting Categorical Summarization Criteria
QTcF increase >=60 msec
|
1 participants
|
2 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Days 1-3 prior to dosing with PF-06282999/Placebo; and Days 4-5Population: Analysis not done due to early termination of study.
Urinary biomarkers included albumin, neutrophil gelatinase-associated lipocalin (NGAL) and Cystatin-C.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1, 3, and 4Population: Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.
The effect of multiple oral doses of PF-06282999 on inflammatory biomarkers was a secondary objective in this study. The biomarkers are tumor necrosis factor (TNF)-alpha, interleukin (IL)-1 beta, IL-6, IL-8, and high-sensitivity C-reactive protein (hsCRP).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Days 1, 3-5Population: Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.
MPO is a heme-containing peroxidase enzyme produced in the bone marrow and stored in the azurophilic granules of neutrophils, where it constitutes up to 5% of the cellular protein. Since PF-06282999 is a mechanism-based inactivator of MPO, it is of interest to evaluate the level of MPO activity in order to investigate the inhibition activity of PF-06282999.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 3Population: Due to early termination of the study, there was not enough participants to perform meaningful analysis on this endpoint. As such, no analysis was done.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 3Population: Due to early termination of the study, no data was collected for this endpoint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 3Population: Due to early termination of the study, no data was collected for this endpoint.
Outcome measures
Outcome data not reported
Adverse Events
PF-06282999 125 mg TID
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
PF-06282999 500 mg BID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PF-06282999 125 mg TID
n=10 participants at risk
All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
|
Placebo
n=19 participants at risk
All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
|
PF-06282999 500 mg BID
n=7 participants at risk
All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
|
|---|---|---|---|
|
Cardiac disorders
Bradycardia
|
0.00%
0/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Sinus arrest
|
0.00%
0/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Tachycardia
|
70.0%
7/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
68.4%
13/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
57.1%
4/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Eye pain
|
10.0%
1/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
30.0%
3/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
26.3%
5/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
20.0%
2/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
28.6%
2/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chills
|
80.0%
8/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
57.9%
11/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
100.0%
10/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
68.4%
13/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Body temperature increased
|
0.00%
0/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
60.0%
6/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
47.4%
9/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
42.9%
3/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
80.0%
8/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
68.4%
13/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
57.1%
4/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
10.0%
1/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
15.8%
3/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
10.0%
1/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
10.5%
2/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
15.8%
3/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
14.3%
1/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Vascular disorders
Pallor
|
0.00%
0/10 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.3%
1/19 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/7 • Baseline through and including 28 calendar days after the last administration of the investigational product, up to approximately 2 months.
All treated participants were analyzed for AEs. The same event may appear as both an AE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
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