Trial Outcomes & Findings for Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia (NCT NCT01243151)
NCT ID: NCT01243151
Last Updated: 2019-01-22
Results Overview
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Dose limiting and intolerable treatment-related AEs were the AEs resulting from drug overdose, drug withdrawal, drug abuse, drug misuse, drug interactions, drug dependency, extravasation, exposure in utero, exposure during breast feeding.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
68 participants
Primary outcome timeframe
Baseline up to Follow-up period (Day 78)
Results posted on
2019-01-22
Participant Flow
Participant milestones
| Measure |
Placebo
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.5 mg/kg
Participants received PF-04950615 1.5 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
14
|
14
|
14
|
14
|
|
Overall Study
Treated
|
12
|
14
|
14
|
13
|
14
|
|
Overall Study
COMPLETED
|
12
|
13
|
13
|
12
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
2
|
0
|
Reasons for withdrawal
| Measure |
Placebo
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.5 mg/kg
Participants received PF-04950615 1.5 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Randomized but not treated
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia
Baseline characteristics by cohort
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
55.3 years
STANDARD_DEVIATION 13.7 • n=5 Participants
|
52.0 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
51.5 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
52.5 years
STANDARD_DEVIATION 14.3 • n=4 Participants
|
55.1 years
STANDARD_DEVIATION 8.8 • n=21 Participants
|
53.2 years
STANDARD_DEVIATION 11.5 • n=10 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
27 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
40 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Follow-up period (Day 78)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Dose limiting and intolerable treatment-related AEs were the AEs resulting from drug overdose, drug withdrawal, drug abuse, drug misuse, drug interactions, drug dependency, extravasation, exposure in utero, exposure during breast feeding.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs)
With intolerable treatment related AEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Dose Limiting and Intolerable Treatment-Related Adverse Events (AEs)
With dose limiting treatment related AEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Follow-up period (Day 78)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. 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. Treatment-related AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. Treatment-emergent are events between first dose of study drug and up to Day 78 that were absent before treatment or that worsened relative to pretreatment state.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs)
Treatment emergent AEs
|
9 participants
|
8 participants
|
5 participants
|
7 participants
|
9 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs)
Treatment emergent SAEs
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Treatment-Related Adverse Events (AEs)
Treatment related AEs
|
3 participants
|
6 participants
|
3 participants
|
2 participants
|
5 participants
|
PRIMARY outcome
Timeframe: Baseline up to Follow-up period (Day 78)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
An AE was any untoward medical occurrence in a participant who received study drug. AE was assessed according to common terminology criteria for adverse events (CTCAE) version 4.0 severity grades- Grade 1: mild (asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated); Grade 2: moderate (minimal, local or non invasive intervention indicated); Grade 3: severe (medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling); Grade 4: Life-threatening consequences; urgent intervention indicated and Grade 5: Death related to AE.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs) by Severity
Grade 1
|
8 participants
|
7 participants
|
5 participants
|
5 participants
|
6 participants
|
|
Number of Participants With Adverse Events (AEs) by Severity
Grade 2
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
3 participants
|
|
Number of Participants With Adverse Events (AEs) by Severity
Grade 3
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) by Severity
Grade 4
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Adverse Events (AEs) by Severity
Grade 5
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Follow-up period (Day 78)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
Criteria: Haemoglobin(Hgb), hematocrit, RBC: \<0.8\*lower limit of normal(LLN),mean corpuscular volume, mean corpuscular Hgb concentration \<0.9\*LLN or\>1.1\*upper limit of normal(ULN), platelet\<0.5\*LLN or\>1.75\*ULN, WBC\<0.6\*LLN or\>1.5\*ULN, lymphocyte, neutrophil\<0.8\*LLN or\>1.2\*ULN, basophil, eosinophil, monocyte\>1.2\*ULN; bilirubin\>1.5\*ULN, aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, lactate dehydrogenase\>3.0\*ULN,total protein,albumin\<0.8\*LLN or\>1.2\*ULN; blood urea nitrogen, creatinine\>1.3\*ULN,uric acid\>1.2\*ULN;sodium\<0.95\*LLNor\>1.05\*ULN,potassium,chloride,calcium,bicarbonate\<0.9\*LLN or\>1.1\*ULN; glucose\<0.6\*LLN or \>1.5\*ULN, urine specific gravity\<1.003 or\>1.030,urine pH\<4.5or\>8,urine glucose, ketones, urine protein,urine blood/Hgb,urobilinogen,bilirubin,nitrite, leukocyte esterase\>=1; urine RBC,WBC\>=20,urine epithelial cells\>=6,urine granular casts,hyaline casts\>1,urine bacteria\>20,partial thromboplastin time,prothrombin:\>1.1\*ULN.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Number of Participants With Laboratory Test Abnormalities
|
7 participants
|
10 participants
|
2 participants
|
7 participants
|
7 participants
|
PRIMARY outcome
Timeframe: Baseline up to Follow-up period (Day 78)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
Criteria for clinically relevant vital signs: supine and standing systolic blood pressure (SBP): less than (\<) 90 millimeter of mercury (mmHg); supine and standing diastolic blood pressure (DBP): \<50 mmHg. Maximum increase from baseline (IFB) or decrease from baseline (DFB) in supine and standing SBP: greater than or equal to (\>=) 30 mmHg and maximum IFB or DFB in supine and standing DBP: \>=20 mmHg. Supine pulse rate: \<40 and greater than (\>) 120 beats per minute (bpm); standing pulse rate: \<40 and \>140 bpm.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Relevant Changes in Vital Signs
Supine SBP
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Relevant Changes in Vital Signs
Maximum IFB in standing SBP
|
4 participants
|
2 participants
|
1 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Clinically Relevant Changes in Vital Signs
Maximum IFB in standing DBP
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Clinically Relevant Changes in Vital Signs
Maximum DFB in supine SBP
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Clinically Relevant Changes in Vital Signs
Maximum DFB in standing DBP
|
2 participants
|
2 participants
|
3 participants
|
4 participants
|
0 participants
|
|
Number of Participants With Clinically Relevant Changes in Vital Signs
Standing DBP
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Relevant Changes in Vital Signs
Maximum IFB in supine SBP
|
2 participants
|
0 participants
|
2 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Clinically Relevant Changes in Vital Signs
Maximum IFB in supine DBP
|
2 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Clinically Relevant Changes in Vital Signs
Maximum DFB in standing SBP
|
0 participants
|
2 participants
|
4 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Relevant Changes in Vital Signs
Maximum DFB in supine DBP
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Clinically Relevant Changes in Vital Signs
Standing SBP
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Clinically Relevant Changes in Vital Signs
Supine DBP
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Relevant Changes in Vital Signs
Supine Pulse Rate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Relevant Changes in Vital Signs
Standing Pulse Rate
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Follow-up period (Day 78)Population: Safety analysis set included all participants who received at least 1 dose of study drug.
Criteria for clinically relevant ECG parameters: PR interval: maximum IFB of \>=25 percent or 50 percent; QRS complex: maximum IFB of \>=25 or 50 percent; QTcF interval (Fridericia's Correction): maximum IFB of \>=30 millisecond (msec) to \<60 msec and maximum IFB of \>=60 msec.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
PR interval: Maximum IFB
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
QRS Complex: Maximum IFB
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
QTcF Interval: Maximum IFB >=30 to <60 msec
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
2 participants
|
|
Number of Participants With Clinically Relevant Changes in Electrocardiogram (ECG) Parameters
QTcF Interval: Maximum IFB >=60 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Follow-up period (Day 78)Population: Safety analysis set included all participants who received at least 1 dose of study drug. Only the participants who received a dose of PF-04950615 0.25, 0.50, 1.0, and 1.50 mg/kg were planned to be analysed for this outcome measure.
The number of participants with at least one positive ADA were summarized for each treatment arm. Participants with positive antibody titer of \>4.32 milligram/milliliter (mg/mL) were considered as ADA positive.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=13 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=14 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Number of Participants With Anti-drug Antibodies (ADA)
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dosePopulation: Pharmacokinetic (PK) parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
AUCtau is area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau =168 hours.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=13 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=14 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615
Day 1
|
596700 nanogram*hour/ milliliter (ng*h/mL)
Geometric Coefficient of Variation 13
|
1224000 nanogram*hour/ milliliter (ng*h/mL)
Geometric Coefficient of Variation 23
|
2697000 nanogram*hour/ milliliter (ng*h/mL)
Geometric Coefficient of Variation 14
|
4253000 nanogram*hour/ milliliter (ng*h/mL)
Geometric Coefficient of Variation 18
|
—
|
|
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of PF-04950615
Day 22
|
749800 nanogram*hour/ milliliter (ng*h/mL)
Geometric Coefficient of Variation 12
|
2134000 nanogram*hour/ milliliter (ng*h/mL)
Geometric Coefficient of Variation 22
|
4766000 nanogram*hour/ milliliter (ng*h/mL)
Geometric Coefficient of Variation 26
|
8351000 nanogram*hour/ milliliter (ng*h/mL)
Geometric Coefficient of Variation 16
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dosePopulation: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Tmax is the time at which maximum plasma concentration (Cmax) occurred.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=13 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=14 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615
Day 1
|
6.00 hour
Interval 0.883 to 9.0
|
3.61 hour
Interval 1.0 to 24.0
|
1.00 hour
Interval 0.867 to 9.18
|
1.00 hour
Interval 0.833 to 24.0
|
—
|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615
Day 22
|
6.00 hour
Interval 0.85 to 9.0
|
1.30 hour
Interval 0.867 to 9.0
|
6.00 hour
Interval 0.85 to 24.0
|
6.00 hour
Interval 0.85 to 9.0
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dosePopulation: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=13 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=14 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04950615
Day 1
|
8077 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 19
|
15080 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 20
|
31380 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 13
|
45110 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 15
|
—
|
|
Maximum Observed Plasma Concentration (Cmax) of PF-04950615
Day 22
|
10170 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 11
|
23680 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 50
|
45820 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 17
|
76180 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 15
|
—
|
SECONDARY outcome
Timeframe: Day 1 and 22: pre-dose and 1, 6, 9, 24 and 72 hours post dosePopulation: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
t1/2 was the time measured for the plasma concentration of PF-04950615 to decrease by one half. t1/2 was calculated as Loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
Outcome measures
| Measure |
Placebo
n=14 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=13 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=14 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Plasma Decay Half-Life (t1/2) of PF-04950615
Day 1
|
50.39 hour
Standard Deviation 6.4231
|
—
|
71.50 hour
Standard Deviation NA
Standard deviation was not calculated as only 1 participant was evaluable.
|
—
|
—
|
|
Plasma Decay Half-Life (t1/2) of PF-04950615
Day 22
|
94.24 hour
Standard Deviation 57.042
|
140.4 hour
Standard Deviation 45.610
|
155.6 hour
Standard Deviation 38.503
|
247.2 hour
Standard Deviation 85.361
|
—
|
SECONDARY outcome
Timeframe: Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dosePopulation: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
CL was calculated as Dose/AUCtau. AUCtau is area under the concentration-time profile from time zero to time tau, the dosing interval, where tau=168 hours.
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=13 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=12 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=14 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Apparent Clearance (CL) of PF-04950615
|
28.98 milliliter per hour (mL/hr)
Geometric Coefficient of Variation 19
|
18.26 milliliter per hour (mL/hr)
Geometric Coefficient of Variation 21
|
17.59 milliliter per hour (mL/hr)
Geometric Coefficient of Variation 26
|
14.05 milliliter per hour (mL/hr)
Geometric Coefficient of Variation 15
|
—
|
SECONDARY outcome
Timeframe: Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dosePopulation: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
Vss was calculated as CL\*MRT. CL was calculated as Dose/AUCtau, where AUCtau was area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau=168 hours. MRT was mean residence time (predicted) extrapolated to infinity.
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=13 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=12 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=14 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Volume of Distribution at Steady State (Vss) of PF-04950615
|
3815 milliliter (mL)
Geometric Coefficient of Variation 111
|
3221 milliliter (mL)
Geometric Coefficient of Variation 20
|
4035 milliliter (mL)
Geometric Coefficient of Variation 19
|
5285 milliliter (mL)
Geometric Coefficient of Variation 25
|
—
|
SECONDARY outcome
Timeframe: Day 22: pre-dose and 1, 6, 9, 24 and 72 hours post dosePopulation: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
Rac was calculated as Day 22 AUCtau divided by Day 1 AUCtau, where AUCtau is area under the concentration-time profile from time zero to time tau (τ), the dosing interval, where tau =168 hours.
Outcome measures
| Measure |
Placebo
n=13 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=13 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=12 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=14 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Accumulation Ratio (Rac) of PF-04950615
|
1.261 ratio
Geometric Coefficient of Variation 12
|
1.685 ratio
Geometric Coefficient of Variation 11
|
1.771 ratio
Geometric Coefficient of Variation 16
|
1.964 ratio
Geometric Coefficient of Variation 9
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 22, 29 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 15
|
-8.21 milligram per deciliter (mg/dL)
Standard Deviation 20.192
|
-77.96 milligram per deciliter (mg/dL)
Standard Deviation 22.181
|
-70.38 milligram per deciliter (mg/dL)
Standard Deviation 25.583
|
-93.25 milligram per deciliter (mg/dL)
Standard Deviation 31.287
|
-93.79 milligram per deciliter (mg/dL)
Standard Deviation 23.841
|
|
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 22
|
-8.96 milligram per deciliter (mg/dL)
Standard Deviation 21.416
|
-84.81 milligram per deciliter (mg/dL)
Standard Deviation 17.345
|
-91.69 milligram per deciliter (mg/dL)
Standard Deviation 20.718
|
-101.92 milligram per deciliter (mg/dL)
Standard Deviation 26.974
|
-102.21 milligram per deciliter (mg/dL)
Standard Deviation 27.277
|
|
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 78
|
-4.36 milligram per deciliter (mg/dL)
Standard Deviation 21.969
|
-9.73 milligram per deciliter (mg/dL)
Standard Deviation 19.796
|
-10.15 milligram per deciliter (mg/dL)
Standard Deviation 14.174
|
-14.09 milligram per deciliter (mg/dL)
Standard Deviation 38.162
|
-65.14 milligram per deciliter (mg/dL)
Standard Deviation 39.500
|
|
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78
Baseline
|
160.96 milligram per deciliter (mg/dL)
Standard Deviation 19.447
|
155.04 milligram per deciliter (mg/dL)
Standard Deviation 18.501
|
160.39 milligram per deciliter (mg/dL)
Standard Deviation 27.326
|
155.62 milligram per deciliter (mg/dL)
Standard Deviation 23.393
|
164.00 milligram per deciliter (mg/dL)
Standard Deviation 21.729
|
|
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 8
|
-6.59 milligram per deciliter (mg/dL)
Standard Deviation 11.258
|
-58.89 milligram per deciliter (mg/dL)
Standard Deviation 16.313
|
-49.08 milligram per deciliter (mg/dL)
Standard Deviation 12.708
|
-68.54 milligram per deciliter (mg/dL)
Standard Deviation 27.477
|
-67.96 milligram per deciliter (mg/dL)
Standard Deviation 27.754
|
|
Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 29
|
-13.71 milligram per deciliter (mg/dL)
Standard Deviation 17.240
|
-82.50 milligram per deciliter (mg/dL)
Standard Deviation 20.848
|
-88.00 milligram per deciliter (mg/dL)
Standard Deviation 25.267
|
-104.33 milligram per deciliter (mg/dL)
Standard Deviation 35.026
|
-104.21 milligram per deciliter (mg/dL)
Standard Deviation 26.207
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 8
|
-4.15 percent change
Standard Deviation 6.983
|
-38.53 percent change
Standard Deviation 11.399
|
-31.59 percent change
Standard Deviation 10.032
|
-44.24 percent change
Standard Deviation 17.213
|
-40.72 percent change
Standard Deviation 14.210
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 15
|
-4.39 percent change
Standard Deviation 12.713
|
-50.68 percent change
Standard Deviation 14.566
|
-45.47 percent change
Standard Deviation 17.016
|
-59.42 percent change
Standard Deviation 19.934
|
-58.02 percent change
Standard Deviation 16.265
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 22
|
-4.94 percent change
Standard Deviation 12.826
|
-54.66 percent change
Standard Deviation 9.140
|
-58.12 percent change
Standard Deviation 13.891
|
-64.59 percent change
Standard Deviation 13.826
|
-62.78 percent change
Standard Deviation 16.665
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 29
|
-8.72 percent change
Standard Deviation 11.074
|
-52.96 percent change
Standard Deviation 11.416
|
-55.25 percent change
Standard Deviation 15.133
|
-65.50 percent change
Standard Deviation 17.327
|
-63.85 percent change
Standard Deviation 14.416
|
|
Percent Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 78
|
-2.97 percent change
Standard Deviation 13.710
|
-5.87 percent change
Standard Deviation 12.391
|
-6.50 percent change
Standard Deviation 9.229
|
-6.94 percent change
Standard Deviation 22.385
|
-40.47 percent change
Standard Deviation 25.797
|
SECONDARY outcome
Timeframe: Day 15, 22, 29 and 36Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL)
Day 15
|
0 Participants
|
6 Participants
|
3 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL)
Day 22
|
0 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL)
Day 29
|
0 Participants
|
6 Participants
|
6 Participants
|
9 Participants
|
10 Participants
|
|
Number of Participants Achieving LDL-C Less Than (<) 70 Milligram Per Deciliter (mg/dL)
Day 36
|
0 Participants
|
0 Participants
|
7 Participants
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Day 15, 22, 29 and 36Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL)
Day 15
|
0 Participants
|
13 Participants
|
10 Participants
|
11 Participants
|
12 Participants
|
|
Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL)
Day 22
|
0 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
|
Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL)
Day 29
|
0 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
13 Participants
|
|
Number of Participants Achieving LDL-C Less Than (<) 100 Milligram Per Deciliter (mg/dL)
Day 36
|
0 Participants
|
2 Participants
|
11 Participants
|
12 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 15, 22, 29 and 36Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=13 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=12 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Number of Participants With Greater Than or Equal to (>=) 50 Percent (%) Reduction in LDL-C From Baseline
|
0 Participants
|
0 Participants
|
5 Participants
|
8 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 22, 29 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78
Baseline
|
142.67 mg/dL
Standard Deviation 20.328
|
144.43 mg/dL
Standard Deviation 20.562
|
150.39 mg/dL
Standard Deviation 20.863
|
143.46 mg/dL
Standard Deviation 25.005
|
156.39 mg/dL
Standard Deviation 28.988
|
|
Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78
Change at Day 8
|
-4.00 mg/dL
Standard Deviation 16.065
|
1.86 mg/dL
Standard Deviation 9.698
|
0.88 mg/dL
Standard Deviation 13.167
|
-1.38 mg/dL
Standard Deviation 10.776
|
-1.75 mg/dL
Standard Deviation 15.074
|
|
Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78
Change at Day 15
|
-1.00 mg/dL
Standard Deviation 14.918
|
13.86 mg/dL
Standard Deviation 14.032
|
8.96 mg/dL
Standard Deviation 13.120
|
6.83 mg/dL
Standard Deviation 13.997
|
8.82 mg/dL
Standard Deviation 21.116
|
|
Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78
Change at Day 22
|
-5.50 mg/dL
Standard Deviation 12.395
|
5.12 mg/dL
Standard Deviation 13.477
|
2.27 mg/dL
Standard Deviation 15.869
|
-3.42 mg/dL
Standard Deviation 10.025
|
6.32 mg/dL
Standard Deviation 13.546
|
|
Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78
Change at Day 29
|
-4.58 mg/dL
Standard Deviation 12.817
|
7.96 mg/dL
Standard Deviation 12.365
|
2.81 mg/dL
Standard Deviation 12.377
|
1.67 mg/dL
Standard Deviation 10.614
|
3.68 mg/dL
Standard Deviation 16.505
|
|
Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78
Change at Day 78
|
-8.92 mg/dL
Standard Deviation 11.057
|
-8.81 mg/dL
Standard Deviation 24.972
|
-6.35 mg/dL
Standard Deviation 13.842
|
-5.42 mg/dL
Standard Deviation 15.639
|
2.46 mg/dL
Standard Deviation 15.163
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 22, 29 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78
Change at Day 29
|
-8.46 mg/dL
Standard Deviation 12.945
|
-55.54 mg/dL
Standard Deviation 14.941
|
-54.08 mg/dL
Standard Deviation 14.850
|
-70.75 mg/dL
Standard Deviation 25.561
|
-63.66 mg/dL
Standard Deviation 16.555
|
|
Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78
Change at Day 78
|
-8.29 mg/dL
Standard Deviation 12.894
|
-8.46 mg/dL
Standard Deviation 18.284
|
-9.38 mg/dL
Standard Deviation 13.489
|
-11.92 mg/dL
Standard Deviation 17.403
|
-39.36 mg/dL
Standard Deviation 19.171
|
|
Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78
Baseline
|
126.54 mg/dL
Standard Deviation 13.662
|
124.04 mg/dL
Standard Deviation 16.454
|
120.32 mg/dL
Standard Deviation 16.199
|
125.62 mg/dL
Standard Deviation 18.377
|
119.57 mg/dL
Standard Deviation 16.804
|
|
Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78
Change at Day 8
|
-7.79 mg/dL
Standard Deviation 15.901
|
-38.39 mg/dL
Standard Deviation 8.150
|
-32.69 mg/dL
Standard Deviation 11.479
|
-46.46 mg/dL
Standard Deviation 17.016
|
-41.36 mg/dL
Standard Deviation 12.796
|
|
Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78
Change at Day 15
|
-9.21 mg/dL
Standard Deviation 10.279
|
-49.11 mg/dL
Standard Deviation 15.713
|
-46.00 mg/dL
Standard Deviation 19.321
|
-61.83 mg/dL
Standard Deviation 22.850
|
-56.29 mg/dL
Standard Deviation 14.567
|
|
Change From Baseline in Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78
Change at Day 22
|
-7.21 mg/dL
Standard Deviation 12.520
|
-52.54 mg/dL
Standard Deviation 13.124
|
-52.38 mg/dL
Standard Deviation 14.826
|
-65.17 mg/dL
Standard Deviation 21.560
|
-59.44 mg/dL
Standard Deviation 19.275
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 22, 29 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78
Change at Day 78
|
-1.25 mg/dL
Standard Deviation 19.760
|
-11.38 mg/dL
Standard Deviation 31.685
|
-11.88 mg/dL
Standard Deviation 20.431
|
-16.42 mg/dL
Standard Deviation 35.522
|
-63.64 mg/dL
Standard Deviation 40.832
|
|
Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78
Baseline
|
237.75 mg/dL
Standard Deviation 24.940
|
233.21 mg/dL
Standard Deviation 26.471
|
239.36 mg/dL
Standard Deviation 32.827
|
242.54 mg/dL
Standard Deviation 31.408
|
247.21 mg/dL
Standard Deviation 24.410
|
|
Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78
Change at Day 8
|
-8.67 mg/dL
Standard Deviation 12.841
|
-61.29 mg/dL
Standard Deviation 18.605
|
-51.96 mg/dL
Standard Deviation 18.394
|
-77.15 mg/dL
Standard Deviation 28.981
|
-71.50 mg/dL
Standard Deviation 28.657
|
|
Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78
Change at Day 15
|
-11.33 mg/dL
Standard Deviation 23.714
|
-77.43 mg/dL
Standard Deviation 22.270
|
-70.96 mg/dL
Standard Deviation 30.673
|
-97.67 mg/dL
Standard Deviation 35.386
|
-94.79 mg/dL
Standard Deviation 24.196
|
|
Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78
Change at Day 22
|
-7.58 mg/dL
Standard Deviation 24.265
|
-85.00 mg/dL
Standard Deviation 21.184
|
-89.81 mg/dL
Standard Deviation 23.173
|
-112.08 mg/dL
Standard Deviation 36.393
|
-100.14 mg/dL
Standard Deviation 26.658
|
|
Change From Baseline in Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78
Change at Day 29
|
-14.67 mg/dL
Standard Deviation 17.127
|
-83.46 mg/dL
Standard Deviation 23.107
|
-88.35 mg/dL
Standard Deviation 26.534
|
-116.75 mg/dL
Standard Deviation 46.591
|
-104.14 mg/dL
Standard Deviation 26.623
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 22, 29 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78
Baseline
|
46.29 mg/dL
Standard Deviation 11.696
|
47.75 mg/dL
Standard Deviation 10.864
|
52.89 mg/dL
Standard Deviation 12.837
|
49.23 mg/dL
Standard Deviation 14.621
|
55.64 mg/dL
Standard Deviation 15.687
|
|
Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 8
|
-1.71 mg/dL
Standard Deviation 5.211
|
0.18 mg/dL
Standard Deviation 5.052
|
0.23 mg/dL
Standard Deviation 3.908
|
-0.92 mg/dL
Standard Deviation 4.821
|
0.00 mg/dL
Standard Deviation 5.349
|
|
Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 15
|
-2.13 mg/dL
Standard Deviation 5.050
|
4.39 mg/dL
Standard Deviation 5.936
|
2.23 mg/dL
Standard Deviation 3.930
|
1.58 mg/dL
Standard Deviation 7.141
|
2.21 mg/dL
Standard Deviation 6.830
|
|
Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 22
|
-0.13 mg/dL
Standard Deviation 4.354
|
3.31 mg/dL
Standard Deviation 4.671
|
2.54 mg/dL
Standard Deviation 6.280
|
0.17 mg/dL
Standard Deviation 4.499
|
4.79 mg/dL
Standard Deviation 7.122
|
|
Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 29
|
-0.46 mg/dL
Standard Deviation 7.149
|
3.77 mg/dL
Standard Deviation 6.559
|
2.46 mg/dL
Standard Deviation 7.304
|
0.92 mg/dL
Standard Deviation 7.122
|
5.36 mg/dL
Standard Deviation 4.483
|
|
Change From Baseline in Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 78
|
-1.29 mg/dL
Standard Deviation 6.315
|
-1.31 mg/dL
Standard Deviation 10.355
|
-1.46 mg/dL
Standard Deviation 4.832
|
-0.25 mg/dL
Standard Deviation 5.586
|
5.14 mg/dL
Standard Deviation 6.443
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 22, 29 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78
Baseline
|
191.46 mg/dL
Standard Deviation 20.999
|
185.46 mg/dL
Standard Deviation 26.890
|
186.46 mg/dL
Standard Deviation 29.171
|
193.31 mg/dL
Standard Deviation 34.922
|
191.57 mg/dL
Standard Deviation 26.355
|
|
Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 78
|
0.04 mg/dL
Standard Deviation 22.738
|
-10.08 mg/dL
Standard Deviation 28.522
|
-10.42 mg/dL
Standard Deviation 19.339
|
-16.17 mg/dL
Standard Deviation 33.701
|
-68.79 mg/dL
Standard Deviation 43.324
|
|
Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 8
|
-6.96 mg/dL
Standard Deviation 10.212
|
-61.46 mg/dL
Standard Deviation 17.091
|
-52.19 mg/dL
Standard Deviation 16.982
|
-76.23 mg/dL
Standard Deviation 27.030
|
-71.50 mg/dL
Standard Deviation 29.506
|
|
Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 15
|
-9.21 mg/dL
Standard Deviation 21.912
|
-81.82 mg/dL
Standard Deviation 22.163
|
-73.19 mg/dL
Standard Deviation 31.471
|
-99.25 mg/dL
Standard Deviation 34.162
|
-97.00 mg/dL
Standard Deviation 25.070
|
|
Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 22
|
-7.46 mg/dL
Standard Deviation 24.362
|
-88.31 mg/dL
Standard Deviation 20.754
|
-92.35 mg/dL
Standard Deviation 21.685
|
-112.25 mg/dL
Standard Deviation 35.962
|
-104.93 mg/dL
Standard Deviation 28.080
|
|
Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 29
|
-14.21 mg/dL
Standard Deviation 13.327
|
-87.23 mg/dL
Standard Deviation 19.842
|
-90.81 mg/dL
Standard Deviation 25.136
|
-117.67 mg/dL
Standard Deviation 45.816
|
-109.50 mg/dL
Standard Deviation 28.156
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 22, 29 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78
Change at Day 22
|
7.75 mg/dL
Standard Deviation 39.352
|
-17.62 mg/dL
Standard Deviation 45.629
|
-3.54 mg/dL
Standard Deviation 39.199
|
-45.29 mg/dL
Standard Deviation 82.959
|
-13.75 mg/dL
Standard Deviation 47.976
|
|
Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78
Change at Day 29
|
-3.00 mg/dL
Standard Deviation 43.389
|
-24.23 mg/dL
Standard Deviation 36.103
|
-14.38 mg/dL
Standard Deviation 53.705
|
-60.21 mg/dL
Standard Deviation 102.224
|
-26.25 mg/dL
Standard Deviation 29.632
|
|
Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78
Change at Day 78
|
52.33 mg/dL
Standard Deviation 177.350
|
-1.77 mg/dL
Standard Deviation 52.488
|
-1.00 mg/dL
Standard Deviation 35.576
|
12.21 mg/dL
Standard Deviation 108.874
|
-18.25 mg/dL
Standard Deviation 40.930
|
|
Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78
Baseline
|
152.92 mg/dL
Standard Deviation 52.761
|
152.00 mg/dL
Standard Deviation 55.166
|
130.36 mg/dL
Standard Deviation 41.199
|
182.27 mg/dL
Standard Deviation 117.963
|
137.96 mg/dL
Standard Deviation 70.799
|
|
Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78
Change at Day 8
|
4.33 mg/dL
Standard Deviation 53.163
|
-12.21 mg/dL
Standard Deviation 52.707
|
-15.69 mg/dL
Standard Deviation 41.689
|
-32.35 mg/dL
Standard Deviation 52.814
|
-2.18 mg/dL
Standard Deviation 66.044
|
|
Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78
Change at Day 15
|
-4.92 mg/dL
Standard Deviation 47.001
|
-19.00 mg/dL
Standard Deviation 32.268
|
-13.92 mg/dL
Standard Deviation 44.051
|
-23.54 mg/dL
Standard Deviation 40.176
|
-16.32 mg/dL
Standard Deviation 32.999
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78
Change at Day 8
|
-2.15 percent change
Standard Deviation 10.895
|
1.38 percent change
Standard Deviation 6.508
|
0.55 percent change
Standard Deviation 8.065
|
-1.17 percent change
Standard Deviation 7.549
|
-0.19 percent change
Standard Deviation 9.462
|
|
Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78
Change at Day 15
|
-0.18 percent change
Standard Deviation 10.362
|
10.03 percent change
Standard Deviation 10.615
|
5.67 percent change
Standard Deviation 8.409
|
4.99 percent change
Standard Deviation 9.450
|
6.11 percent change
Standard Deviation 14.252
|
|
Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78
Change at Day 22
|
-3.38 percent change
Standard Deviation 8.315
|
4.01 percent change
Standard Deviation 9.735
|
1.90 percent change
Standard Deviation 10.085
|
-1.61 percent change
Standard Deviation 6.994
|
4.92 percent change
Standard Deviation 9.366
|
|
Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78
Change at Day 29
|
-2.62 percent change
Standard Deviation 8.538
|
5.82 percent change
Standard Deviation 8.244
|
1.80 percent change
Standard Deviation 8.623
|
1.20 percent change
Standard Deviation 7.435
|
3.51 percent change
Standard Deviation 11.179
|
|
Percent Change From Baseline in Lipid Parameters: Apolipoprotein A1 (ApoA1) at Day 8, 15, 22, 29 and 78
Change at Day 78
|
-5.85 percent change
Standard Deviation 7.270
|
-4.61 percent change
Standard Deviation 15.035
|
-3.48 percent change
Standard Deviation 9.082
|
-3.77 percent change
Standard Deviation 10.868
|
3.20 percent change
Standard Deviation 11.505
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78
Change at Day 29
|
-6.61 percent change
Standard Deviation 10.206
|
-44.37 percent change
Standard Deviation 10.311
|
-45.51 percent change
Standard Deviation 12.176
|
-55.74 percent change
Standard Deviation 15.477
|
-53.15 percent change
Standard Deviation 10.682
|
|
Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78
Change at Day 78
|
-6.24 percent change
Standard Deviation 10.119
|
-6.11 percent change
Standard Deviation 13.750
|
-7.95 percent change
Standard Deviation 11.527
|
-8.40 percent change
Standard Deviation 13.819
|
-33.66 percent change
Standard Deviation 17.828
|
|
Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78
Change at Day 8
|
-5.78 percent change
Standard Deviation 12.548
|
-31.37 percent change
Standard Deviation 7.019
|
-27.78 percent change
Standard Deviation 9.784
|
-36.61 percent change
Standard Deviation 12.248
|
-34.71 percent change
Standard Deviation 9.872
|
|
Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78
Change at Day 15
|
-7.08 percent change
Standard Deviation 7.974
|
-39.63 percent change
Standard Deviation 11.339
|
-38.94 percent change
Standard Deviation 15.373
|
-49.03 percent change
Standard Deviation 15.663
|
-47.45 percent change
Standard Deviation 12.424
|
|
Percent Change From Baseline In Lipid Parameters: Apolipoprotein B (ApoB) at Day 8, 15, 22, 29 and 78
Change at Day 22
|
-5.17 percent change
Standard Deviation 9.548
|
-42.06 percent change
Standard Deviation 8.865
|
-43.87 percent change
Standard Deviation 10.909
|
-51.52 percent change
Standard Deviation 12.657
|
-49.45 percent change
Standard Deviation 13.498
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78
Change at Day 8
|
-3.73 percent change
Standard Deviation 5.594
|
-26.43 percent change
Standard Deviation 7.582
|
-22.11 percent change
Standard Deviation 8.292
|
-31.68 percent change
Standard Deviation 11.543
|
-28.70 percent change
Standard Deviation 10.002
|
|
Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78
Change at Day 15
|
-4.46 percent change
Standard Deviation 10.151
|
-33.35 percent change
Standard Deviation 9.238
|
-30.59 percent change
Standard Deviation 13.208
|
-39.69 percent change
Standard Deviation 13.307
|
-38.77 percent change
Standard Deviation 10.906
|
|
Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78
Change at Day 22
|
-2.61 percent change
Standard Deviation 9.708
|
-36.44 percent change
Standard Deviation 7.736
|
-37.81 percent change
Standard Deviation 9.438
|
-45.23 percent change
Standard Deviation 11.101
|
-40.69 percent change
Standard Deviation 10.542
|
|
Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78
Change at Day 29
|
-6.12 percent change
Standard Deviation 7.275
|
-35.76 percent change
Standard Deviation 8.855
|
-37.12 percent change
Standard Deviation 11.045
|
-46.81 percent change
Standard Deviation 15.606
|
-42.24 percent change
Standard Deviation 9.692
|
|
Percent Change From Baseline In Lipid Parameters: Total Cholesterol at Day 8, 15, 22, 29 and 78
Change at Day 78
|
-0.90 percent change
Standard Deviation 8.320
|
-4.28 percent change
Standard Deviation 13.040
|
-5.11 percent change
Standard Deviation 8.907
|
-5.49 percent change
Standard Deviation 14.026
|
-26.16 percent change
Standard Deviation 17.561
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 29
|
0.02 percent change
Standard Deviation 14.389
|
9.02 percent change
Standard Deviation 14.218
|
4.55 percent change
Standard Deviation 12.030
|
3.56 percent change
Standard Deviation 12.870
|
11.44 percent change
Standard Deviation 10.270
|
|
Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 78
|
-1.40 percent change
Standard Deviation 13.662
|
0.24 percent change
Standard Deviation 19.628
|
-2.24 percent change
Standard Deviation 8.900
|
-2.32 percent change
Standard Deviation 11.310
|
11.35 percent change
Standard Deviation 13.124
|
|
Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 8
|
-2.75 percent change
Standard Deviation 11.363
|
1.26 percent change
Standard Deviation 10.469
|
0.31 percent change
Standard Deviation 7.401
|
-2.64 percent change
Standard Deviation 9.055
|
0.61 percent change
Standard Deviation 10.217
|
|
Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 15
|
-3.98 percent change
Standard Deviation 10.134
|
10.54 percent change
Standard Deviation 14.406
|
4.72 percent change
Standard Deviation 8.025
|
4.39 percent change
Standard Deviation 11.643
|
5.56 percent change
Standard Deviation 13.089
|
|
Percent Change From Baseline In Lipid Parameters: High Density Lipoprotein Cholesterol (HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 22
|
0.48 percent change
Standard Deviation 9.693
|
8.01 percent change
Standard Deviation 10.268
|
5.49 percent change
Standard Deviation 11.126
|
1.78 percent change
Standard Deviation 9.431
|
9.83 percent change
Standard Deviation 14.119
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 8
|
-3.85 percent change
Standard Deviation 5.557
|
-33.32 percent change
Standard Deviation 8.161
|
-28.56 percent change
Standard Deviation 8.868
|
-39.11 percent change
Standard Deviation 12.195
|
-36.85 percent change
Standard Deviation 11.918
|
|
Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 15
|
-4.33 percent change
Standard Deviation 11.789
|
-44.54 percent change
Standard Deviation 12.261
|
-40.54 percent change
Standard Deviation 15.915
|
-50.81 percent change
Standard Deviation 14.320
|
-50.85 percent change
Standard Deviation 12.789
|
|
Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 22
|
-3.27 percent change
Standard Deviation 12.091
|
-47.43 percent change
Standard Deviation 7.666
|
-50.15 percent change
Standard Deviation 10.327
|
-57.08 percent change
Standard Deviation 10.801
|
-54.61 percent change
Standard Deviation 11.948
|
|
Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 78
|
-0.13 percent change
Standard Deviation 11.797
|
-4.84 percent change
Standard Deviation 14.681
|
-5.97 percent change
Standard Deviation 10.711
|
-6.62 percent change
Standard Deviation 16.960
|
-36.83 percent change
Standard Deviation 24.401
|
|
Percent Change From Baseline In Lipid Parameters: Non High Density Lipoprotein Cholesterol (Non HDL-C) at Day 8, 15, 22, 29 and 78
Change at Day 29
|
-7.45 percent change
Standard Deviation 7.261
|
-46.96 percent change
Standard Deviation 8.425
|
-49.29 percent change
Standard Deviation 12.890
|
-59.12 percent change
Standard Deviation 15.643
|
-56.98 percent change
Standard Deviation 10.994
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 29 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78
Change at Day 8
|
-2.25 percent change
Standard Deviation 30.696
|
0.47 percent change
Standard Deviation 36.664
|
-9.47 percent change
Standard Deviation 33.634
|
-15.52 percent change
Standard Deviation 25.106
|
-1.90 percent change
Standard Deviation 35.794
|
|
Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78
Change at Day 15
|
-1.76 percent change
Standard Deviation 38.074
|
-9.97 percent change
Standard Deviation 19.639
|
-8.88 percent change
Standard Deviation 29.664
|
-8.87 percent change
Standard Deviation 16.916
|
-8.36 percent change
Standard Deviation 32.603
|
|
Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78
Change at Day 22
|
5.29 percent change
Standard Deviation 25.939
|
-9.14 percent change
Standard Deviation 24.192
|
-2.82 percent change
Standard Deviation 31.720
|
-13.00 percent change
Standard Deviation 28.724
|
-8.11 percent change
Standard Deviation 31.027
|
|
Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78
Change at Day 29
|
-6.35 percent change
Standard Deviation 24.168
|
-15.68 percent change
Standard Deviation 17.890
|
-13.18 percent change
Standard Deviation 39.826
|
-19.81 percent change
Standard Deviation 34.900
|
-18.32 percent change
Standard Deviation 21.062
|
|
Percent Change From Baseline In Lipid Parameters: Triglycerides (TG) at Day 8, 15, 22, 29 and 78
Change at Day 78
|
35.06 percent change
Standard Deviation 123.074
|
4.27 percent change
Standard Deviation 33.925
|
-2.18 percent change
Standard Deviation 32.081
|
4.74 percent change
Standard Deviation 43.369
|
-12.42 percent change
Standard Deviation 28.128
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 8
|
0.00 nanometer (nm)
Standard Deviation 0.600
|
0.07 nanometer (nm)
Standard Deviation 0.334
|
0.06 nanometer (nm)
Standard Deviation 0.399
|
-0.02 nanometer (nm)
Standard Deviation 0.446
|
0.09 nanometer (nm)
Standard Deviation 0.380
|
|
Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 36
|
-0.13 nanometer (nm)
Standard Deviation 0.382
|
0.01 nanometer (nm)
Standard Deviation 0.352
|
0.22 nanometer (nm)
Standard Deviation 0.518
|
0.07 nanometer (nm)
Standard Deviation 0.509
|
0.09 nanometer (nm)
Standard Deviation 0.766
|
|
Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 50
|
-0.04 nanometer (nm)
Standard Deviation 0.487
|
-0.08 nanometer (nm)
Standard Deviation 0.285
|
-0.18 nanometer (nm)
Standard Deviation 0.463
|
-0.02 nanometer (nm)
Standard Deviation 0.327
|
0.11 nanometer (nm)
Standard Deviation 0.595
|
|
Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 64
|
-0.19 nanometer (nm)
Standard Deviation 0.601
|
-0.19 nanometer (nm)
Standard Deviation 0.413
|
-0.18 nanometer (nm)
Standard Deviation 0.426
|
-0.08 nanometer (nm)
Standard Deviation 0.379
|
0.04 nanometer (nm)
Standard Deviation 0.497
|
|
Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Baseline
|
20.37 nanometer (nm)
Standard Deviation 0.713
|
20.48 nanometer (nm)
Standard Deviation 0.833
|
21.04 nanometer (nm)
Standard Deviation 1.059
|
20.66 nanometer (nm)
Standard Deviation 1.018
|
21.18 nanometer (nm)
Standard Deviation 1.132
|
|
Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 15
|
-0.23 nanometer (nm)
Standard Deviation 0.661
|
-0.13 nanometer (nm)
Standard Deviation 0.403
|
0.19 nanometer (nm)
Standard Deviation 0.463
|
-0.08 nanometer (nm)
Standard Deviation 0.496
|
0.05 nanometer (nm)
Standard Deviation 0.372
|
|
Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 22
|
-0.05 nanometer (nm)
Standard Deviation 0.403
|
0.24 nanometer (nm)
Standard Deviation 0.333
|
0.10 nanometer (nm)
Standard Deviation 0.567
|
0.08 nanometer (nm)
Standard Deviation 0.564
|
0.08 nanometer (nm)
Standard Deviation 0.507
|
|
Change From Baseline In Low Density Lipoprotein Cholesterol (LDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 78
|
-0.13 nanometer (nm)
Standard Deviation 0.367
|
0.11 nanometer (nm)
Standard Deviation 0.551
|
-0.15 nanometer (nm)
Standard Deviation 0.533
|
-0.09 nanometer (nm)
Standard Deviation 0.323
|
0.08 nanometer (nm)
Standard Deviation 0.435
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 15
|
-21.08 nanomoles per liter (nmol/L)
Standard Deviation 348.697
|
-521.15 nanomoles per liter (nmol/L)
Standard Deviation 397.925
|
-450.31 nanomoles per liter (nmol/L)
Standard Deviation 458.385
|
-567.67 nanomoles per liter (nmol/L)
Standard Deviation 533.371
|
-470.93 nanomoles per liter (nmol/L)
Standard Deviation 348.889
|
|
Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 36
|
-58.92 nanomoles per liter (nmol/L)
Standard Deviation 273.321
|
-245.77 nanomoles per liter (nmol/L)
Standard Deviation 326.908
|
-534.62 nanomoles per liter (nmol/L)
Standard Deviation 480.776
|
-697.50 nanomoles per liter (nmol/L)
Standard Deviation 565.896
|
-540.93 nanomoles per liter (nmol/L)
Standard Deviation 394.389
|
|
Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 50
|
38.58 nanomoles per liter (nmol/L)
Standard Deviation 341.805
|
19.31 nanomoles per liter (nmol/L)
Standard Deviation 136.299
|
-88.15 nanomoles per liter (nmol/L)
Standard Deviation 311.715
|
-450.17 nanomoles per liter (nmol/L)
Standard Deviation 475.951
|
-514.64 nanomoles per liter (nmol/L)
Standard Deviation 444.216
|
|
Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 78
|
-17.25 nanomoles per liter (nmol/L)
Standard Deviation 256.900
|
-70.92 nanomoles per liter (nmol/L)
Standard Deviation 356.896
|
39.00 nanomoles per liter (nmol/L)
Standard Deviation 417.482
|
-57.33 nanomoles per liter (nmol/L)
Standard Deviation 364.799
|
-299.43 nanomoles per liter (nmol/L)
Standard Deviation 315.715
|
|
Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Baseline
|
1436.42 nanomoles per liter (nmol/L)
Standard Deviation 476.114
|
1285.21 nanomoles per liter (nmol/L)
Standard Deviation 510.295
|
982.14 nanomoles per liter (nmol/L)
Standard Deviation 660.248
|
1163.69 nanomoles per liter (nmol/L)
Standard Deviation 625.676
|
870.07 nanomoles per liter (nmol/L)
Standard Deviation 564.004
|
|
Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 8
|
-104.67 nanomoles per liter (nmol/L)
Standard Deviation 421.388
|
-435.86 nanomoles per liter (nmol/L)
Standard Deviation 323.733
|
-304.85 nanomoles per liter (nmol/L)
Standard Deviation 390.365
|
-459.31 nanomoles per liter (nmol/L)
Standard Deviation 379.905
|
-321.71 nanomoles per liter (nmol/L)
Standard Deviation 311.160
|
|
Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 22
|
-62.92 nanomoles per liter (nmol/L)
Standard Deviation 369.272
|
-665.23 nanomoles per liter (nmol/L)
Standard Deviation 392.357
|
-450.85 nanomoles per liter (nmol/L)
Standard Deviation 531.247
|
-696.42 nanomoles per liter (nmol/L)
Standard Deviation 589.692
|
-513.07 nanomoles per liter (nmol/L)
Standard Deviation 392.796
|
|
Change From Baseline In Small Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 64
|
35.58 nanomoles per liter (nmol/L)
Standard Deviation 410.428
|
102.15 nanomoles per liter (nmol/L)
Standard Deviation 222.450
|
60.00 nanomoles per liter (nmol/L)
Standard Deviation 245.038
|
-165.33 nanomoles per liter (nmol/L)
Standard Deviation 302.403
|
-441.29 nanomoles per liter (nmol/L)
Standard Deviation 420.139
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Baseline
|
302.67 nmol/L
Standard Deviation 103.271
|
257.57 nmol/L
Standard Deviation 98.358
|
196.57 nmol/L
Standard Deviation 128.296
|
237.31 nmol/L
Standard Deviation 135.958
|
171.14 nmol/L
Standard Deviation 114.370
|
|
Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 8
|
-45.33 nmol/L
Standard Deviation 77.296
|
-70.71 nmol/L
Standard Deviation 66.675
|
-52.77 nmol/L
Standard Deviation 77.953
|
-89.62 nmol/L
Standard Deviation 96.271
|
-58.00 nmol/L
Standard Deviation 69.471
|
|
Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 15
|
-17.92 nmol/L
Standard Deviation 90.062
|
-88.15 nmol/L
Standard Deviation 85.983
|
-83.85 nmol/L
Standard Deviation 91.519
|
-105.25 nmol/L
Standard Deviation 124.532
|
-83.29 nmol/L
Standard Deviation 70.268
|
|
Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 22
|
-17.33 nmol/L
Standard Deviation 72.118
|
-113.54 nmol/L
Standard Deviation 84.567
|
-77.54 nmol/L
Standard Deviation 104.141
|
-126.50 nmol/L
Standard Deviation 134.014
|
-95.93 nmol/L
Standard Deviation 80.612
|
|
Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 36
|
-26.58 nmol/L
Standard Deviation 70.370
|
-39.85 nmol/L
Standard Deviation 75.660
|
-103.46 nmol/L
Standard Deviation 96.958
|
-128.83 nmol/L
Standard Deviation 128.898
|
-95.93 nmol/L
Standard Deviation 75.083
|
|
Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 50
|
-7.42 nmol/L
Standard Deviation 67.594
|
16.77 nmol/L
Standard Deviation 46.490
|
-1.23 nmol/L
Standard Deviation 63.816
|
-76.00 nmol/L
Standard Deviation 105.963
|
-89.57 nmol/L
Standard Deviation 89.102
|
|
Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 64
|
-7.50 nmol/L
Standard Deviation 91.363
|
32.69 nmol/L
Standard Deviation 52.454
|
16.08 nmol/L
Standard Deviation 54.920
|
-18.75 nmol/L
Standard Deviation 63.438
|
-75.14 nmol/L
Standard Deviation 84.820
|
|
Change From Baseline In Medium Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 78
|
-12.25 nmol/L
Standard Deviation 53.177
|
-2.69 nmol/L
Standard Deviation 76.234
|
18.23 nmol/L
Standard Deviation 84.810
|
-5.08 nmol/L
Standard Deviation 77.809
|
-54.79 nmol/L
Standard Deviation 59.832
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Baseline
|
367.42 nmol/L
Standard Deviation 251.928
|
424.71 nmol/L
Standard Deviation 336.502
|
578.57 nmol/L
Standard Deviation 346.792
|
459.00 nmol/L
Standard Deviation 341.699
|
639.36 nmol/L
Standard Deviation 378.728
|
|
Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 8
|
16.42 nmol/L
Standard Deviation 238.022
|
-135.36 nmol/L
Standard Deviation 140.673
|
-138.69 nmol/L
Standard Deviation 108.767
|
-163.85 nmol/L
Standard Deviation 183.861
|
-219.64 nmol/L
Standard Deviation 173.835
|
|
Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 15
|
-71.67 nmol/L
Standard Deviation 265.452
|
-198.31 nmol/L
Standard Deviation 154.965
|
-173.08 nmol/L
Standard Deviation 158.586
|
-248.25 nmol/L
Standard Deviation 218.091
|
-297.36 nmol/L
Standard Deviation 201.235
|
|
Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 22
|
-26.50 nmol/L
Standard Deviation 137.911
|
-162.69 nmol/L
Standard Deviation 170.876
|
-237.00 nmol/L
Standard Deviation 173.930
|
-271.58 nmol/L
Standard Deviation 219.097
|
-311.36 nmol/L
Standard Deviation 215.078
|
|
Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 36
|
-38.17 nmol/L
Standard Deviation 164.092
|
-93.15 nmol/L
Standard Deviation 170.770
|
-236.23 nmol/L
Standard Deviation 180.758
|
-244.75 nmol/L
Standard Deviation 219.917
|
-333.64 nmol/L
Standard Deviation 266.184
|
|
Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 50
|
18.83 nmol/L
Standard Deviation 159.906
|
-70.38 nmol/L
Standard Deviation 111.722
|
-177.46 nmol/L
Standard Deviation 177.244
|
-226.75 nmol/L
Standard Deviation 161.785
|
-337.00 nmol/L
Standard Deviation 215.720
|
|
Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 64
|
-45.08 nmol/L
Standard Deviation 227.314
|
-114.31 nmol/L
Standard Deviation 208.922
|
-79.69 nmol/L
Standard Deviation 168.660
|
-147.75 nmol/L
Standard Deviation 155.138
|
-341.57 nmol/L
Standard Deviation 243.742
|
|
Change From Baseline In Large Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 78
|
-50.08 nmol/L
Standard Deviation 133.655
|
-31.23 nmol/L
Standard Deviation 254.307
|
-108.15 nmol/L
Standard Deviation 159.176
|
-85.25 nmol/L
Standard Deviation 91.821
|
-215.43 nmol/L
Standard Deviation 230.488
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Baseline
|
1898.83 nmol/L
Standard Deviation 393.934
|
1789.29 nmol/L
Standard Deviation 297.035
|
1626.14 nmol/L
Standard Deviation 474.106
|
1694.15 nmol/L
Standard Deviation 439.012
|
1549.71 nmol/L
Standard Deviation 332.241
|
|
Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 8
|
-100.42 nmol/L
Standard Deviation 326.272
|
-598.00 nmol/L
Standard Deviation 253.302
|
-460.08 nmol/L
Standard Deviation 351.468
|
-664.00 nmol/L
Standard Deviation 332.371
|
-557.86 nmol/L
Standard Deviation 245.049
|
|
Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 15
|
-87.67 nmol/L
Standard Deviation 269.313
|
-756.46 nmol/L
Standard Deviation 300.314
|
-658.08 nmol/L
Standard Deviation 400.172
|
-851.67 nmol/L
Standard Deviation 447.423
|
-790.14 nmol/L
Standard Deviation 269.961
|
|
Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 22
|
-89.17 nmol/L
Standard Deviation 344.100
|
-877.62 nmol/L
Standard Deviation 276.218
|
-735.92 nmol/L
Standard Deviation 462.348
|
-1015.00 nmol/L
Standard Deviation 482.252
|
-846.71 nmol/L
Standard Deviation 303.019
|
|
Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 36
|
-113.58 nmol/L
Standard Deviation 299.598
|
-345.46 nmol/L
Standard Deviation 272.208
|
-805.46 nmol/L
Standard Deviation 413.417
|
-986.75 nmol/L
Standard Deviation 466.474
|
-894.21 nmol/L
Standard Deviation 284.814
|
|
Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 50
|
63.00 nmol/L
Standard Deviation 303.420
|
-45.23 nmol/L
Standard Deviation 128.264
|
-278.23 nmol/L
Standard Deviation 268.441
|
-705.00 nmol/L
Standard Deviation 486.227
|
-879.50 nmol/L
Standard Deviation 322.993
|
|
Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 64
|
-0.33 nmol/L
Standard Deviation 287.226
|
10.62 nmol/L
Standard Deviation 191.872
|
-14.77 nmol/L
Standard Deviation 231.884
|
-309.25 nmol/L
Standard Deviation 396.535
|
-801.36 nmol/L
Standard Deviation 354.429
|
|
Change From Baseline In Total Low Density Lipoprotein Cholesterol (LDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Change at Day 78
|
-60.83 nmol/L
Standard Deviation 285.233
|
-105.62 nmol/L
Standard Deviation 319.186
|
-72.69 nmol/L
Standard Deviation 364.420
|
-143.42 nmol/L
Standard Deviation 432.459
|
-529.57 nmol/L
Standard Deviation 294.496
|
SECONDARY outcome
Timeframe: Baseline, Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population was defined as all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78
Baseline
|
48.83 ng/mL
Standard Deviation 22.741
|
43.96 ng/mL
Standard Deviation 23.731
|
43.07 ng/mL
Standard Deviation 23.580
|
34.10 ng/mL
Standard Deviation 20.316
|
44.12 ng/mL
Standard Deviation 24.425
|
|
Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78
Day 8
|
48.53 ng/mL
Standard Deviation 21.549
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
|
Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78
Day 15
|
50.42 ng/mL
Standard Deviation 22.170
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
|
Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78
Day 22
|
52.58 ng/mL
Standard Deviation 29.516
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
|
Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78
Day 36
|
51.80 ng/mL
Standard Deviation 24.231
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
|
Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78
Day 50
|
48.21 ng/mL
Standard Deviation 19.973
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
|
Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78
Day 64
|
51.95 ng/mL
Standard Deviation 25.584
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
|
Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Levels at Baseline, Day 8, 15, 22, 36, 50, 64 and 78
Day 78
|
43.75 ng/mL
Standard Deviation 23.686
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
NA ng/mL
Standard Deviation NA
Data could not be evaluated since the value was below Lower Limit of Quantification (LLQ).
|
SECONDARY outcome
Timeframe: Day 8, 15, 21, 36, 57 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78
Day 8
|
0.23 mg/dL
Standard Deviation 0.252
|
0.26 mg/dL
Standard Deviation 0.204
|
0.18 mg/dL
Standard Deviation 0.251
|
0.42 mg/dL
Standard Deviation 0.506
|
0.16 mg/dL
Standard Deviation 0.191
|
|
C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78
Day 15
|
0.30 mg/dL
Standard Deviation 0.385
|
0.23 mg/dL
Standard Deviation 0.206
|
0.25 mg/dL
Standard Deviation 0.433
|
0.38 mg/dL
Standard Deviation 0.553
|
0.20 mg/dL
Standard Deviation 0.293
|
|
C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78
Day 21
|
0.27 mg/dL
Standard Deviation 0.320
|
0.23 mg/dL
Standard Deviation 0.194
|
0.23 mg/dL
Standard Deviation 0.441
|
0.32 mg/dL
Standard Deviation 0.464
|
0.21 mg/dL
Standard Deviation 0.364
|
|
C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78
Day 36
|
0.34 mg/dL
Standard Deviation 0.407
|
0.27 mg/dL
Standard Deviation 0.255
|
0.27 mg/dL
Standard Deviation 0.450
|
0.28 mg/dL
Standard Deviation 0.306
|
0.26 mg/dL
Standard Deviation 0.541
|
|
C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78
Day 57
|
0.21 mg/dL
Standard Deviation 0.205
|
0.36 mg/dL
Standard Deviation 0.502
|
0.21 mg/dL
Standard Deviation 0.368
|
0.51 mg/dL
Standard Deviation 0.985
|
0.18 mg/dL
Standard Deviation 0.220
|
|
C-Reactive Protein Levels at Day 8, 15, 21, 36, 57 and 78
Day 78
|
0.32 mg/dL
Standard Deviation 0.400
|
0.33 mg/dL
Standard Deviation 0.522
|
0.21 mg/dL
Standard Deviation 0.291
|
0.54 mg/dL
Standard Deviation 1.175
|
0.15 mg/dL
Standard Deviation 0.141
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had atleast 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 8
|
23.26 micromole/liter (umol/L)
Standard Deviation 3.147
|
22.79 micromole/liter (umol/L)
Standard Deviation 3.210
|
20.64 micromole/liter (umol/L)
Standard Deviation 7.390
|
19.74 micromole/liter (umol/L)
Standard Deviation 5.807
|
21.49 micromole/liter (umol/L)
Standard Deviation 5.767
|
|
Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 15
|
23.13 micromole/liter (umol/L)
Standard Deviation 5.511
|
24.04 micromole/liter (umol/L)
Standard Deviation 3.831
|
22.39 micromole/liter (umol/L)
Standard Deviation 6.412
|
19.04 micromole/liter (umol/L)
Standard Deviation 5.768
|
21.87 micromole/liter (umol/L)
Standard Deviation 7.229
|
|
Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 22
|
22.74 micromole/liter (umol/L)
Standard Deviation 5.162
|
23.67 micromole/liter (umol/L)
Standard Deviation 4.626
|
21.60 micromole/liter (umol/L)
Standard Deviation 6.865
|
21.57 micromole/liter (umol/L)
Standard Deviation 6.763
|
21.02 micromole/liter (umol/L)
Standard Deviation 6.531
|
|
Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 36
|
23.16 micromole/liter (umol/L)
Standard Deviation 5.582
|
23.33 micromole/liter (umol/L)
Standard Deviation 5.223
|
21.72 micromole/liter (umol/L)
Standard Deviation 5.804
|
19.18 micromole/liter (umol/L)
Standard Deviation 6.676
|
22.59 micromole/liter (umol/L)
Standard Deviation 5.060
|
|
Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 50
|
23.25 micromole/liter (umol/L)
Standard Deviation 3.395
|
23.73 micromole/liter (umol/L)
Standard Deviation 4.924
|
23.37 micromole/liter (umol/L)
Standard Deviation 5.005
|
22.83 micromole/liter (umol/L)
Standard Deviation 6.103
|
22.61 micromole/liter (umol/L)
Standard Deviation 8.649
|
|
Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 64
|
25.13 micromole/liter (umol/L)
Standard Deviation 4.747
|
23.02 micromole/liter (umol/L)
Standard Deviation 6.617
|
22.89 micromole/liter (umol/L)
Standard Deviation 5.298
|
20.73 micromole/liter (umol/L)
Standard Deviation 5.579
|
22.92 micromole/liter (umol/L)
Standard Deviation 7.777
|
|
Small High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 78
|
22.79 micromole/liter (umol/L)
Standard Deviation 4.176
|
22.25 micromole/liter (umol/L)
Standard Deviation 6.245
|
21.85 micromole/liter (umol/L)
Standard Deviation 5.610
|
20.16 micromole/liter (umol/L)
Standard Deviation 5.633
|
21.11 micromole/liter (umol/L)
Standard Deviation 6.976
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 8
|
1.90 umol/L
Standard Deviation 2.158
|
4.24 umol/L
Standard Deviation 3.086
|
5.12 umol/L
Standard Deviation 3.778
|
6.24 umol/L
Standard Deviation 4.067
|
5.29 umol/L
Standard Deviation 5.057
|
|
Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 15
|
2.80 umol/L
Standard Deviation 2.888
|
4.88 umol/L
Standard Deviation 2.467
|
4.82 umol/L
Standard Deviation 3.408
|
8.69 umol/L
Standard Deviation 5.054
|
5.84 umol/L
Standard Deviation 6.642
|
|
Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 22
|
3.26 umol/L
Standard Deviation 2.394
|
5.60 umol/L
Standard Deviation 3.836
|
6.81 umol/L
Standard Deviation 5.102
|
5.71 umol/L
Standard Deviation 3.563
|
7.08 umol/L
Standard Deviation 6.606
|
|
Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 36
|
4.29 umol/L
Standard Deviation 3.516
|
4.75 umol/L
Standard Deviation 3.583
|
5.31 umol/L
Standard Deviation 3.738
|
8.34 umol/L
Standard Deviation 6.035
|
6.06 umol/L
Standard Deviation 4.500
|
|
Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 50
|
3.68 umol/L
Standard Deviation 3.615
|
3.48 umol/L
Standard Deviation 2.869
|
3.28 umol/L
Standard Deviation 3.059
|
4.94 umol/L
Standard Deviation 3.596
|
7.50 umol/L
Standard Deviation 7.664
|
|
Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 64
|
3.50 umol/L
Standard Deviation 3.254
|
2.82 umol/L
Standard Deviation 2.722
|
3.74 umol/L
Standard Deviation 3.358
|
4.73 umol/L
Standard Deviation 3.772
|
7.04 umol/L
Standard Deviation 6.034
|
|
Medium High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 78
|
3.65 umol/L
Standard Deviation 3.592
|
3.28 umol/L
Standard Deviation 3.006
|
2.88 umol/L
Standard Deviation 3.098
|
4.19 umol/L
Standard Deviation 4.274
|
5.37 umol/L
Standard Deviation 6.117
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 64
|
5.78 umol/L
Standard Deviation 3.155
|
5.98 umol/L
Standard Deviation 2.471
|
7.47 umol/L
Standard Deviation 3.564
|
7.41 umol/L
Standard Deviation 5.359
|
7.65 umol/L
Standard Deviation 2.848
|
|
Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 8
|
5.88 umol/L
Standard Deviation 3.636
|
6.81 umol/L
Standard Deviation 3.963
|
7.97 umol/L
Standard Deviation 3.491
|
6.87 umol/L
Standard Deviation 4.608
|
8.08 umol/L
Standard Deviation 4.144
|
|
Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 15
|
5.90 umol/L
Standard Deviation 3.514
|
6.11 umol/L
Standard Deviation 3.684
|
9.05 umol/L
Standard Deviation 3.604
|
7.03 umol/L
Standard Deviation 3.833
|
8.36 umol/L
Standard Deviation 3.815
|
|
Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 22
|
6.23 umol/L
Standard Deviation 3.497
|
6.85 umol/L
Standard Deviation 3.152
|
7.93 umol/L
Standard Deviation 3.943
|
6.75 umol/L
Standard Deviation 3.544
|
8.88 umol/L
Standard Deviation 4.919
|
|
Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 36
|
5.70 umol/L
Standard Deviation 2.763
|
6.97 umol/L
Standard Deviation 4.091
|
8.25 umol/L
Standard Deviation 4.123
|
7.74 umol/L
Standard Deviation 4.124
|
8.94 umol/L
Standard Deviation 3.656
|
|
Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 50
|
5.95 umol/L
Standard Deviation 3.293
|
5.98 umol/L
Standard Deviation 3.452
|
7.58 umol/L
Standard Deviation 4.065
|
7.90 umol/L
Standard Deviation 4.608
|
9.06 umol/L
Standard Deviation 4.073
|
|
Large High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 78
|
5.17 umol/L
Standard Deviation 2.934
|
5.61 umol/L
Standard Deviation 2.271
|
7.74 umol/L
Standard Deviation 3.788
|
7.16 umol/L
Standard Deviation 4.958
|
8.56 umol/L
Standard Deviation 3.747
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 50
|
32.88 umol/L
Standard Deviation 4.380
|
33.21 umol/L
Standard Deviation 3.305
|
34.22 umol/L
Standard Deviation 4.704
|
35.69 umol/L
Standard Deviation 6.808
|
39.16 umol/L
Standard Deviation 5.797
|
|
Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 64
|
34.41 umol/L
Standard Deviation 6.210
|
31.84 umol/L
Standard Deviation 4.979
|
34.08 umol/L
Standard Deviation 3.930
|
32.88 umol/L
Standard Deviation 5.865
|
37.59 umol/L
Standard Deviation 4.620
|
|
Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 8
|
31.07 umol/L
Standard Deviation 5.339
|
33.84 umol/L
Standard Deviation 4.326
|
33.72 umol/L
Standard Deviation 5.344
|
32.85 umol/L
Standard Deviation 7.554
|
34.83 umol/L
Standard Deviation 5.854
|
|
Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 15
|
31.83 umol/L
Standard Deviation 6.791
|
35.03 umol/L
Standard Deviation 5.080
|
36.27 umol/L
Standard Deviation 5.541
|
34.77 umol/L
Standard Deviation 7.503
|
36.09 umol/L
Standard Deviation 7.021
|
|
Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 22
|
32.20 umol/L
Standard Deviation 5.874
|
36.13 umol/L
Standard Deviation 4.392
|
36.32 umol/L
Standard Deviation 5.852
|
34.02 umol/L
Standard Deviation 6.845
|
36.97 umol/L
Standard Deviation 5.193
|
|
Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 36
|
33.13 umol/L
Standard Deviation 6.369
|
35.04 umol/L
Standard Deviation 4.876
|
35.27 umol/L
Standard Deviation 4.077
|
35.28 umol/L
Standard Deviation 7.642
|
37.59 umol/L
Standard Deviation 4.453
|
|
Total High Density Lipoprotein-Cholesterol (HDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 78
|
31.61 umol/L
Standard Deviation 4.440
|
31.14 umol/L
Standard Deviation 5.035
|
32.48 umol/L
Standard Deviation 4.043
|
31.51 umol/L
Standard Deviation 6.288
|
35.01 umol/L
Standard Deviation 2.773
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 8
|
48.02 nmol/L
Standard Deviation 19.760
|
38.97 nmol/L
Standard Deviation 17.319
|
36.84 nmol/L
Standard Deviation 16.561
|
36.69 nmol/L
Standard Deviation 18.980
|
28.94 nmol/L
Standard Deviation 18.740
|
|
Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 15
|
54.04 nmol/L
Standard Deviation 18.566
|
30.55 nmol/L
Standard Deviation 13.832
|
29.98 nmol/L
Standard Deviation 22.143
|
26.65 nmol/L
Standard Deviation 12.759
|
23.56 nmol/L
Standard Deviation 12.336
|
|
Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 22
|
50.14 nmol/L
Standard Deviation 17.239
|
28.86 nmol/L
Standard Deviation 11.540
|
20.91 nmol/L
Standard Deviation 14.011
|
23.23 nmol/L
Standard Deviation 10.315
|
20.94 nmol/L
Standard Deviation 14.117
|
|
Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 36
|
55.32 nmol/L
Standard Deviation 16.242
|
44.25 nmol/L
Standard Deviation 18.962
|
24.22 nmol/L
Standard Deviation 15.588
|
25.43 nmol/L
Standard Deviation 14.978
|
21.39 nmol/L
Standard Deviation 12.817
|
|
Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 50
|
50.04 nmol/L
Standard Deviation 19.344
|
57.12 nmol/L
Standard Deviation 20.032
|
34.65 nmol/L
Standard Deviation 14.144
|
28.56 nmol/L
Standard Deviation 16.992
|
24.69 nmol/L
Standard Deviation 14.503
|
|
Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 64
|
51.82 nmol/L
Standard Deviation 22.057
|
57.12 nmol/L
Standard Deviation 22.475
|
42.09 nmol/L
Standard Deviation 12.780
|
35.91 nmol/L
Standard Deviation 16.296
|
18.81 nmol/L
Standard Deviation 12.118
|
|
Small Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 78
|
50.44 nmol/L
Standard Deviation 24.319
|
48.44 nmol/L
Standard Deviation 15.108
|
46.30 nmol/L
Standard Deviation 90.153
|
39.72 nmol/L
Standard Deviation 18.003
|
27.71 nmol/L
Standard Deviation 17.448
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 64
|
46.29 nmol/L
Standard Deviation 48.067
|
35.02 nmol/L
Standard Deviation 23.457
|
21.05 nmol/L
Standard Deviation 16.456
|
38.27 nmol/L
Standard Deviation 28.436
|
24.48 nmol/L
Standard Deviation 15.117
|
|
Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 8
|
43.84 nmol/L
Standard Deviation 31.720
|
31.89 nmol/L
Standard Deviation 16.142
|
21.82 nmol/L
Standard Deviation 12.659
|
32.02 nmol/L
Standard Deviation 20.966
|
34.56 nmol/L
Standard Deviation 28.586
|
|
Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 15
|
45.18 nmol/L
Standard Deviation 33.883
|
29.93 nmol/L
Standard Deviation 12.067
|
31.38 nmol/L
Standard Deviation 25.580
|
34.84 nmol/L
Standard Deviation 26.305
|
33.91 nmol/L
Standard Deviation 26.636
|
|
Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 22
|
42.08 nmol/L
Standard Deviation 30.055
|
32.32 nmol/L
Standard Deviation 16.184
|
35.10 nmol/L
Standard Deviation 20.188
|
39.47 nmol/L
Standard Deviation 22.121
|
30.62 nmol/L
Standard Deviation 17.768
|
|
Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 36
|
54.42 nmol/L
Standard Deviation 43.631
|
38.26 nmol/L
Standard Deviation 25.474
|
19.35 nmol/L
Standard Deviation 9.353
|
29.31 nmol/L
Standard Deviation 18.029
|
26.48 nmol/L
Standard Deviation 18.798
|
|
Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 50
|
40.91 nmol/L
Standard Deviation 29.614
|
39.62 nmol/L
Standard Deviation 26.490
|
25.31 nmol/L
Standard Deviation 19.813
|
34.01 nmol/L
Standard Deviation 20.440
|
25.04 nmol/L
Standard Deviation 19.770
|
|
Medium Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 78
|
31.68 nmol/L
Standard Deviation 26.579
|
33.54 nmol/L
Standard Deviation 19.946
|
30.74 nmol/L
Standard Deviation 24.781
|
38.25 nmol/L
Standard Deviation 33.529
|
30.55 nmol/L
Standard Deviation 35.729
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 64
|
8.41 nmol/L
Standard Deviation 12.714
|
3.42 nmol/L
Standard Deviation 3.224
|
2.13 nmol/L
Standard Deviation 3.096
|
6.33 nmol/L
Standard Deviation 8.829
|
2.51 nmol/L
Standard Deviation 3.305
|
|
Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 8
|
4.66 nmol/L
Standard Deviation 7.571
|
3.91 nmol/L
Standard Deviation 3.291
|
2.43 nmol/L
Standard Deviation 3.119
|
5.18 nmol/L
Standard Deviation 5.910
|
4.63 nmol/L
Standard Deviation 8.128
|
|
Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 15
|
2.84 nmol/L
Standard Deviation 3.086
|
3.69 nmol/L
Standard Deviation 3.202
|
2.36 nmol/L
Standard Deviation 2.425
|
5.58 nmol/L
Standard Deviation 6.071
|
3.19 nmol/L
Standard Deviation 4.364
|
|
Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 22
|
4.07 nmol/L
Standard Deviation 4.367
|
3.65 nmol/L
Standard Deviation 3.692
|
2.52 nmol/L
Standard Deviation 3.384
|
2.75 nmol/L
Standard Deviation 2.821
|
4.01 nmol/L
Standard Deviation 7.348
|
|
Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 36
|
6.72 nmol/L
Standard Deviation 7.795
|
3.85 nmol/L
Standard Deviation 3.261
|
2.17 nmol/L
Standard Deviation 2.615
|
4.27 nmol/L
Standard Deviation 3.359
|
3.91 nmol/L
Standard Deviation 6.648
|
|
Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 50
|
5.93 nmol/L
Standard Deviation 6.572
|
3.25 nmol/L
Standard Deviation 2.712
|
2.47 nmol/L
Standard Deviation 3.347
|
5.57 nmol/L
Standard Deviation 7.217
|
3.31 nmol/L
Standard Deviation 4.728
|
|
Large Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 78
|
9.00 nmol/L
Standard Deviation 15.067
|
4.08 nmol/L
Standard Deviation 3.494
|
2.34 nmol/L
Standard Deviation 2.993
|
6.68 nmol/L
Standard Deviation 9.279
|
2.89 nmol/L
Standard Deviation 3.806
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 50
|
96.89 nmol/L
Standard Deviation 39.372
|
100.00 nmol/L
Standard Deviation 44.554
|
62.46 nmol/L
Standard Deviation 29.705
|
68.13 nmol/L
Standard Deviation 29.699
|
53.04 nmol/L
Standard Deviation 31.259
|
|
Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 64
|
106.51 nmol/L
Standard Deviation 66.108
|
95.55 nmol/L
Standard Deviation 40.252
|
65.25 nmol/L
Standard Deviation 27.024
|
80.51 nmol/L
Standard Deviation 45.939
|
45.81 nmol/L
Standard Deviation 24.781
|
|
Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 78
|
91.11 nmol/L
Standard Deviation 38.064
|
86.06 nmol/L
Standard Deviation 31.763
|
79.37 nmol/L
Standard Deviation 39.806
|
84.64 nmol/L
Standard Deviation 50.216
|
61.16 nmol/L
Standard Deviation 42.496
|
|
Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 8
|
96.56 nmol/L
Standard Deviation 37.874
|
74.79 nmol/L
Standard Deviation 27.473
|
61.11 nmol/L
Standard Deviation 26.738
|
73.92 nmol/L
Standard Deviation 40.221
|
68.14 nmol/L
Standard Deviation 37.104
|
|
Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 15
|
102.08 nmol/L
Standard Deviation 40.769
|
64.16 nmol/L
Standard Deviation 24.573
|
63.68 nmol/L
Standard Deviation 44.340
|
67.07 nmol/L
Standard Deviation 36.861
|
60.66 nmol/L
Standard Deviation 33.367
|
|
Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 22
|
96.27 nmol/L
Standard Deviation 42.925
|
64.85 nmol/L
Standard Deviation 23.841
|
58.53 nmol/L
Standard Deviation 26.727
|
65.47 nmol/L
Standard Deviation 29.936
|
55.53 nmol/L
Standard Deviation 23.928
|
|
Total Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Levels at Day 8, 15, 22, 36, 50, 64 and 78
Day 36
|
116.48 nmol/L
Standard Deviation 59.693
|
86.36 nmol/L
Standard Deviation 40.242
|
45.72 nmol/L
Standard Deviation 20.487
|
58.99 nmol/L
Standard Deviation 29.746
|
51.76 nmol/L
Standard Deviation 26.621
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Day 8
|
8.73 nm
Standard Deviation 0.454
|
8.81 nm
Standard Deviation 0.359
|
9.02 nm
Standard Deviation 0.421
|
8.88 nm
Standard Deviation 0.513
|
9.01 nm
Standard Deviation 0.427
|
|
High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Day 15
|
8.72 nm
Standard Deviation 0.356
|
8.75 nm
Standard Deviation 0.364
|
9.06 nm
Standard Deviation 0.371
|
8.95 nm
Standard Deviation 0.427
|
9.04 nm
Standard Deviation 0.425
|
|
High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Day 22
|
8.73 nm
Standard Deviation 0.379
|
8.84 nm
Standard Deviation 0.331
|
8.99 nm
Standard Deviation 0.362
|
8.92 nm
Standard Deviation 0.471
|
9.07 nm
Standard Deviation 0.412
|
|
High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Day 36
|
8.75 nm
Standard Deviation 0.406
|
8.85 nm
Standard Deviation 0.369
|
9.05 nm
Standard Deviation 0.470
|
9.03 nm
Standard Deviation 0.479
|
9.09 nm
Standard Deviation 0.342
|
|
High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Day 50
|
8.73 nm
Standard Deviation 0.398
|
8.77 nm
Standard Deviation 0.384
|
8.98 nm
Standard Deviation 0.419
|
8.95 nm
Standard Deviation 0.547
|
9.04 nm
Standard Deviation 0.403
|
|
High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Day 64
|
8.75 nm
Standard Deviation 0.303
|
8.77 nm
Standard Deviation 0.307
|
9.01 nm
Standard Deviation 0.441
|
8.96 nm
Standard Deviation 0.571
|
8.96 nm
Standard Deviation 0.386
|
|
High Density Lipoprotein-Cholesterol (HDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Day 78
|
8.68 nm
Standard Deviation 0.339
|
8.76 nm
Standard Deviation 0.263
|
9.05 nm
Standard Deviation 0.484
|
8.99 nm
Standard Deviation 0.507
|
9.08 nm
Standard Deviation 0.395
|
SECONDARY outcome
Timeframe: Day 8, 15, 22, 36, 50, 64 and 78Population: Pharmacodynamic analysis population included all enrolled participants who received at least 1 dose of study medication and had at least 1 pharmacodynamic parameter. Here 'n' signifies those participants who were evaluable at the specified time points for each reporting group, respectively.
Outcome measures
| Measure |
Placebo
n=12 Participants
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 Participants
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 Participants
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.0 mg/kg
n=13 Participants
Participants received PF-04950615 1.0 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.50 mg/kg
n=14 Participants
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Day 50
|
51.57 nm
Standard Deviation 9.261
|
47.62 nm
Standard Deviation 4.463
|
53.62 nm
Standard Deviation 15.032
|
52.48 nm
Standard Deviation 9.738
|
54.14 nm
Standard Deviation 10.801
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Day 8
|
48.57 nm
Standard Deviation 6.907
|
51.21 nm
Standard Deviation 5.290
|
50.15 nm
Standard Deviation 8.341
|
51.37 nm
Standard Deviation 6.934
|
50.07 nm
Standard Deviation 6.934
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Day 15
|
48.13 nm
Standard Deviation 4.918
|
52.85 nm
Standard Deviation 5.284
|
53.57 nm
Standard Deviation 10.417
|
53.47 nm
Standard Deviation 8.371
|
50.54 nm
Standard Deviation 5.837
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Day 22
|
52.42 nm
Standard Deviation 6.876
|
54.09 nm
Standard Deviation 6.152
|
54.28 nm
Standard Deviation 9.695
|
50.22 nm
Standard Deviation 4.799
|
53.95 nm
Standard Deviation 8.878
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Day 36
|
51.42 nm
Standard Deviation 7.249
|
51.81 nm
Standard Deviation 6.030
|
53.69 nm
Standard Deviation 10.745
|
55.33 nm
Standard Deviation 9.556
|
52.40 nm
Standard Deviation 9.080
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Day 64
|
50.51 nm
Standard Deviation 9.062
|
46.58 nm
Standard Deviation 6.099
|
48.60 nm
Standard Deviation 7.661
|
52.95 nm
Standard Deviation 8.965
|
51.74 nm
Standard Deviation 5.163
|
|
Very Low Density Lipoprotein-Cholesterol (VLDL-C) Particle Size at Day 8, 15, 22, 36, 50, 64 and 78
Day 78
|
52.17 nm
Standard Deviation 11.873
|
48.95 nm
Standard Deviation 4.820
|
49.41 nm
Standard Deviation 7.249
|
50.99 nm
Standard Deviation 8.967
|
49.63 nm
Standard Deviation 6.762
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
PF-04950615 0.25 mg/kg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
PF-04950615 0.50 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
PF-04950615 1.00 mg/kg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
PF-04950615 1.50 mg/kg
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=12 participants at risk
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 participants at risk
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 participants at risk
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.00 mg/kg
n=13 participants at risk
Participants recieved a single dose of PF-04950615 1.0 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
PF-04950615 1.50 mg/kg
n=14 participants at risk
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14 • Number of events 1
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
Other adverse events
| Measure |
Placebo
n=12 participants at risk
Participants received placebo matched to PF-04950615 once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.25 mg/kg
n=14 participants at risk
Participants received PF-04950615 0.25 milligram per kilogram (mg/kg), intravenous (IV) infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 0.50 mg/kg
n=14 participants at risk
Participants received PF-04950615 0.50 mg/kg, IV infusion once daily on Day 1, 8, 15 and 22 in 28 days treatment period.
|
PF-04950615 1.00 mg/kg
n=13 participants at risk
Participants recieved a single dose of PF-04950615 1.0 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
PF-04950615 1.50 mg/kg
n=14 participants at risk
Participants received a single dose of PF-04950615 1.50 milligram/kilogram (mg/kg), intravenous (IV) infusion once on Day 1,8,15 and 22.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Atrioventricular block first degree
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Cardiac disorders
Bundle branch block left
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Application site dermatitis
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Energy increased
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Fatigue
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Influenza like illness
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Puncture site haemorrhage
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Vessel puncture site haematoma
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Bronchitis
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Fungal infection
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Sinusitis
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
14.3%
2/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Epicondylitis
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
15.4%
2/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Investigations
QRS axis abnormal
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Headache
|
16.7%
2/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
28.6%
4/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
35.7%
5/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
8.3%
1/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
14.3%
2/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
21.4%
3/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.7%
1/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/12
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
7.1%
1/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/13
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious event during the study.
|
0.00%
0/14
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non serious in another participant, or one participant may have experienced both a serious and non serious 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