Dyslipidemia, Hypercholesterolemia
Conditions
Keywords
Hypercholesterolemia, Dyslipidemia, LDL, Cholesterol, High Cholesterol, PF-04950615, RN316
Brief summary
The primary objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of a single dose of PF-04950615 (RN316) in volunteers on stable doses of atorvastatin. PF-04950615 (RN316) is an investigational drug that is currently being studies as a cholesterol lowering therapy.
Interventions
RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.
RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.
Sponsors
Study design
Eligibility
Inclusion criteria
* On stable doses of atorvastatin (40 mg daily) for 45 days prior to Day 1. * BMI 18.5 to 40 kg/m2 inclusive, and body weight equal or lower than 150 kg.
Exclusion criteria
* History of a cardiovascular event (e.g., MI ) during the past year. * Poorly controlled Type 1 or Type 2 Diabetes mellitus (definition: uncontrolled diabetes is defined as HBIAc \>9%). * Poorly controlled hypertension (uncontrolled hypertension is defined as a systolic blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm Hg, even with treatment). Subjects who have hypertension and are controlled on stable dosages of anti-hypertensive medications can be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615 | 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | — |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | — |
| Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | — |
| Plasma Decay Half-Life (t1/2) of PF-04950615 | 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Plasma decay half-life is the time measured for the plasma concentration of PF-04950615 to decrease by one half. |
| Systemic Clearance (CL) of PF-04950615 | 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. |
| Volume of Distribution at Steady State (Vss) of PF-04950615 | 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of PF-04950615 | 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | — |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Atorvastatin | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4 | AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 12 hours. |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7 | — |
| Maximum Observed Plasma Concentration (Cmax) of Atorvastatin | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7 | — |
| Plasma Decay Half-Life (t1/2) of Atorvastatin | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7 | Plasma decay half-life is the time measured for the plasma concentration of atorvastatin to decrease by one half. |
| Apparent Oral Clearance (CL/F) of Atorvastatin | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. |
| Apparent Volume of Distribution (Vz/F) of Atorvastatin | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 | Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration. |
| Duration of Low Density Lipoprotein (LDL) Lowering Effects | Day 4 to Day 64 | In this outcome measure duration of the lipid-lowering effects was reported. Lipid lowering was defined as decrease in LDL-C levels by greater than or equal to 15 percent. |
| Number of Participants With Toxicity or Intolerable Dose Criteria | Day 1 up to Day 64 | Toxicity criteria included any of the following: serious adverse event; increased liver transaminases (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]: increased to greater than \[\>\] 5\*upper limit of normal reference range \[ULN\]); increased bilirubin (in absence of ALT or AST elevations, common terminology criteria for adverse events \[CTCAE\] greater than or equal to \[\>=\] Grade 2); pancreatitis, increased serum creatinine (CTCAE \>= Grade 2); creatine kinase, hyperglycemia or hypoglycemia, diarrhea or enteritis or nausea (CTCAE \>= Grade 3); decreased platelet count (less than \[\<\] 100000 per microliter); prolongation of QT interval with Fridericia's Correction (QTcF) (QTcF \>500 millisecond \[msec\] \[CTCAE \>= Grade 3\] or increase from baseline of \>=60 msec) and other considered appropriate by investigator. CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. |
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Day 64 | An AE was any untoward medical occurrence in a 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-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. Adverse events included both serious and non-serious adverse events. |
| Number of Participants With Treatment-Emergent Adverse Events by Severity | Day 1 up to Day 64 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. AEs were assessed for severity by CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. Categories with at least 1 participant were reported |
| Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 | Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration. |
| Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Physical Examination | Day 1 up to Day 64 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. Complete physical examination was conducted to assess skin, ears, throat, cardiac, respiratory, gastrointestinal, and musculoskeletal systems for systemic AEs. |
| Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs | Day 1 up to Day 64 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. Vital sign parameters body temperature, blood pressure and heart rate were assessed to identify systemic adverse events. AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported. CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. Categories with at least 1 participant were reported |
| Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) Parameters | Day 1 up to Day 64 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. ECG parameters RR interval, PR interval, QRS complex, QT interval, \[Bazett's Correction\], QTcF interval \[Fridericia's Correction\] were assessed to identify systemic AEs. AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported. CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. Categories with at least 1 participant were reported. |
| Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters | Day 1 up to Day 64 | Laboratory parameters alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, albumin, hemoglobin, protein, amylase, creatine kinase, lipase, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets, white blood cells, bicarbonate, chloride, potassium, sodium, bilirubin, blood urea nitrogen, c-reactive protein , calcium, creatinine, direct bilirubin, glucose, magnesium, phosphate, uric acid, hematocrit, partial thromboplastin time , prothrombin time, red blood cells , urine pH, urine specific gravity were assessed to identify systemic AEs. AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported. Same participant may be reported in more than 1 CTCAE severity grade. Categories with at least 1 participant were reported. |
| Number of Participants With Positive Anti-drug Antibodies (ADA) | Day 1 up to Day 64 | Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies. Results with titer value \>=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure. |
| Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | Day 1 up to Day 64 | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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. |
| Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 | Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration. |
| Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 | Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration. |
| Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 | Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration. |
| Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 | Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration. |
| Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 | Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration. |
| Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 | Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration. |
| Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 | Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration. |
| Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 | Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration. |
| Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 | Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration. |
| Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 | Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration. |
| Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 | Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration. |
| Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 | Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin Participants received single intravenous infusion dose of PF-04950615 (RN316) 4 milligram per kilogram (mg/kg) on Day 4 along with sponsor provided atorvastatin 40 milligram (mg) tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64. | 12 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin Participants received single intravenous infusion dose of PF-04950615 (RN316) 0.5 mg/kg on Day 4 along with sponsor provided atorvastatin 40 mg tablet orally once daily from Day 1 to 7. Participants were on self-administered stable atorvastatin therapy, 40 mg orally once daily prior to Day 1 and after treatment phase (Day 7). Participants were followed up to Day 64. | 12 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Enrolled but not treated | 1 | 0 |
| Overall Study | Site Closure | 0 | 1 |
Baseline characteristics
| Characteristic | PF-04950615 (RN316) 4 mg/kg + Atorvastatin | PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 3 Participants | 6 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 9 Participants | 18 Participants |
| Sex: Female, Male Female | 7 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 12 | 11 / 12 |
| serious Total, serious adverse events | 1 / 12 | 0 / 12 |
Outcome results
Apparent Oral Clearance (CL/F) of Atorvastatin
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Apparent Oral Clearance (CL/F) of Atorvastatin | 557.50 liter per hour | Standard Deviation 238.33 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Apparent Oral Clearance (CL/F) of Atorvastatin | 448.70 liter per hour | Standard Deviation 196.91 |
Apparent Volume of Distribution (Vz/F) of Atorvastatin
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' is signifying those participants who were evaluable for this measure for each group respectively.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Apparent Volume of Distribution (Vz/F) of Atorvastatin | 3950 liter | Standard Deviation 1952.8 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Apparent Volume of Distribution (Vz/F) of Atorvastatin | 3353 liter | Standard Deviation 1960.8 |
Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Atorvastatin
AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 12 hours.
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Atorvastatin | 71.73 nanogram*hour per milliliter | Standard Deviation 32.22 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Atorvastatin | 89.17 nanogram*hour per milliliter | Standard Deviation 33.25 |
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of PF-04950615
Time frame: 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of PF-04950615 | 17960000 nanogram*hour per milliliter | Standard Deviation 2828500 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of PF-04950615 | 1094000 nanogram*hour per milliliter | Standard Deviation 123640 |
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615
Time frame: 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Population: Pharmacokinetic (PK) parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615 | 17950000 nanogram*hour per milliliter | Standard Deviation 2779600 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615 | 933800 nanogram*hour per milliliter | Standard Deviation 376350 |
Maximum Observed Plasma Concentration (Cmax) of Atorvastatin
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Maximum Observed Plasma Concentration (Cmax) of Atorvastatin | 15.79 nanogram per milliliter | Standard Deviation 8.81 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Maximum Observed Plasma Concentration (Cmax) of Atorvastatin | 20.68 nanogram per milliliter | Standard Deviation 10.58 |
Maximum Observed Plasma Concentration (Cmax) of PF-04950615
Time frame: 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | 105000 nanogram per milliliter | Standard Deviation 16587 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | 14030 nanogram per milliliter | Standard Deviation 1680 |
Plasma Decay Half-Life (t1/2) of Atorvastatin
Plasma decay half-life is the time measured for the plasma concentration of atorvastatin to decrease by one half.
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Plasma Decay Half-Life (t1/2) of Atorvastatin | 5.12 hour | Standard Deviation 1.38 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Plasma Decay Half-Life (t1/2) of Atorvastatin | 5.09 hour | Standard Deviation 0.74 |
Plasma Decay Half-Life (t1/2) of PF-04950615
Plasma decay half-life is the time measured for the plasma concentration of PF-04950615 to decrease by one half.
Time frame: 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Plasma Decay Half-Life (t1/2) of PF-04950615 | 157.50 hour | Standard Deviation 33.22 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Plasma Decay Half-Life (t1/2) of PF-04950615 | 61.00 hour | Standard Deviation 8.89 |
Systemic Clearance (CL) of PF-04950615
CL is a quantitative measure of the rate at which a drug substance is removed from the body.
Time frame: 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Systemic Clearance (CL) of PF-04950615 | 0.0185 liter per hour | Standard Deviation 0.0041 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Systemic Clearance (CL) of PF-04950615 | 0.0392 liter per hour | Standard Deviation 0.0031 |
Time to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin
Time frame: 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin | 1.16 hour |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin | 1.00 hour |
Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615
Time frame: 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | 2.59 hour |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | 4.00 hour |
Volume of Distribution at Steady State (Vss) of PF-04950615
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug.
Time frame: 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Population: PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. Here, 'Overall number of participants analyzed' signifies those participants who were evaluable for this measure for each group respectively.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Volume of Distribution at Steady State (Vss) of PF-04950615 | 4.248 liter | Standard Deviation 1.099 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Volume of Distribution at Steady State (Vss) of PF-04950615 | 3.436 liter | Standard Deviation 0.583 |
Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.
Time frame: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 15 | 6.80 milligram per deciliter | Standard Deviation 8.3 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 36 | 10.30 milligram per deciliter | Standard Deviation 10.87 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 7 | 3.40 milligram per deciliter | Standard Deviation 10.93 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 43 | 7.80 milligram per deciliter | Standard Deviation 10.73 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 22 | 5.70 milligram per deciliter | Standard Deviation 11.13 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 50 | 6.50 milligram per deciliter | Standard Deviation 8.64 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 6 | -1.70 milligram per deciliter | Standard Deviation 10.79 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 57 | 4.40 milligram per deciliter | Standard Deviation 11.77 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 29 | 7.50 milligram per deciliter | Standard Deviation 13.43 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 64 | 0.50 milligram per deciliter | Standard Deviation 10.82 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 5 | -3.00 milligram per deciliter | Standard Deviation 10.95 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 64 | 22.10 milligram per deciliter | Standard Deviation 19.44 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 5 | 2.80 milligram per deciliter | Standard Deviation 8.7 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 6 | -5.60 milligram per deciliter | Standard Deviation 8.07 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 7 | -1.50 milligram per deciliter | Standard Deviation 9.22 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 15 | 12.10 milligram per deciliter | Standard Deviation 18.48 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 22 | 16.10 milligram per deciliter | Standard Deviation 18.71 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 29 | 11.40 milligram per deciliter | Standard Deviation 27.34 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 36 | 11.50 milligram per deciliter | Standard Deviation 15.09 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 43 | 14.90 milligram per deciliter | Standard Deviation 15.96 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 50 | 5.20 milligram per deciliter | Standard Deviation 22.03 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 57 | 24.50 milligram per deciliter | Standard Deviation 12.51 |
Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Time frame: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 15 | -41.90 milligram per deciliter | Standard Deviation 19.41 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 36 | -41.10 milligram per deciliter | Standard Deviation 15.09 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 7 | -28.30 milligram per deciliter | Standard Deviation 12.57 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 43 | -27.30 milligram per deciliter | Standard Deviation 7.48 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 22 | -44.00 milligram per deciliter | Standard Deviation 17.67 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 50 | -10.40 milligram per deciliter | Standard Deviation 10.53 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 6 | -22.10 milligram per deciliter | Standard Deviation 10.05 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 57 | -5.10 milligram per deciliter | Standard Deviation 15.7 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 29 | -45.80 milligram per deciliter | Standard Deviation 17.61 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 64 | 2.30 milligram per deciliter | Standard Deviation 10.7 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 5 | -10.90 milligram per deciliter | Standard Deviation 7.48 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 64 | 5.80 milligram per deciliter | Standard Deviation 20.99 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 5 | -13.10 milligram per deciliter | Standard Deviation 8.49 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 6 | -24.90 milligram per deciliter | Standard Deviation 12.88 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 7 | -29.50 milligram per deciliter | Standard Deviation 16.75 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 15 | -21.70 milligram per deciliter | Standard Deviation 19.84 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 22 | -3.30 milligram per deciliter | Standard Deviation 18.78 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 29 | -1.10 milligram per deciliter | Standard Deviation 23.99 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 36 | -2.70 milligram per deciliter | Standard Deviation 19.76 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 43 | -0.60 milligram per deciliter | Standard Deviation 18.47 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 50 | -4.60 milligram per deciliter | Standard Deviation 20.74 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 57 | 4.70 milligram per deciliter | Standard Deviation 15.51 |
Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Time frame: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 15 | 4.50 milligram per deciliter | Standard Deviation 8.01 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 36 | 3.80 milligram per deciliter | Standard Deviation 5.52 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 7 | -0.90 milligram per deciliter | Standard Deviation 4.41 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 43 | 6.10 milligram per deciliter | Standard Deviation 6.59 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 22 | 6.70 milligram per deciliter | Standard Deviation 4.65 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 50 | 2.80 milligram per deciliter | Standard Deviation 6.27 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 6 | -2.10 milligram per deciliter | Standard Deviation 4.16 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 57 | 2.70 milligram per deciliter | Standard Deviation 5.26 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 29 | 6.50 milligram per deciliter | Standard Deviation 6.53 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 64 | -0.0 milligram per deciliter | Standard Deviation 6.02 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 5 | -1.30 milligram per deciliter | Standard Deviation 5.6 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 64 | 2.40 milligram per deciliter | Standard Deviation 7.95 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 5 | -2.20 milligram per deciliter | Standard Deviation 7.95 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 6 | -2.40 milligram per deciliter | Standard Deviation 11.71 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 7 | -2.40 milligram per deciliter | Standard Deviation 12.63 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 15 | 5.90 milligram per deciliter | Standard Deviation 5.13 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 22 | 2.80 milligram per deciliter | Standard Deviation 5.41 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 29 | 0.50 milligram per deciliter | Standard Deviation 5.99 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 36 | 1.90 milligram per deciliter | Standard Deviation 8.2 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 43 | 3.10 milligram per deciliter | Standard Deviation 5.39 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 50 | 1.70 milligram per deciliter | Standard Deviation 7.71 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 57 | 4.20 milligram per deciliter | Standard Deviation 9.22 |
Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Time frame: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 15 | -52.40 milligram per deciliter | Standard Deviation 35.31 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 36 | -55.50 milligram per deciliter | Standard Deviation 23.64 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 7 | -33.30 milligram per deciliter | Standard Deviation 22.42 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 43 | -32.30 milligram per deciliter | Standard Deviation 15.64 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 22 | -57.20 milligram per deciliter | Standard Deviation 30.71 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 50 | -11.40 milligram per deciliter | Standard Deviation 13.27 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 6 | -28.50 milligram per deciliter | Standard Deviation 17.22 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 57 | -1.50 milligram per deciliter | Standard Deviation 22.25 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 29 | -56.90 milligram per deciliter | Standard Deviation 35.21 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 64 | 6.20 milligram per deciliter | Standard Deviation 24.62 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 5 | -14.30 milligram per deciliter | Standard Deviation 17.79 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 64 | 12.10 milligram per deciliter | Standard Deviation 33.42 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 5 | -16.2 milligram per deciliter | Standard Deviation 11.56 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 6 | -34.00 milligram per deciliter | Standard Deviation 19.13 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 7 | -47.20 milligram per deciliter | Standard Deviation 20.66 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 15 | -25.90 milligram per deciliter | Standard Deviation 31.94 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 22 | 2.10 milligram per deciliter | Standard Deviation 36.01 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 29 | 9.40 milligram per deciliter | Standard Deviation 33.12 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 36 | 3.40 milligram per deciliter | Standard Deviation 33.09 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 43 | 8.80 milligram per deciliter | Standard Deviation 34.18 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 50 | 4.10 milligram per deciliter | Standard Deviation 29.02 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 57 | 10.90 milligram per deciliter | Standard Deviation 35.79 |
Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Time frame: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 15 | -62.50 milligram per deciliter | Standard Deviation 39.4 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 36 | -60.00 milligram per deciliter | Standard Deviation 29.56 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 7 | -36.40 milligram per deciliter | Standard Deviation 24.5 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 43 | -35.00 milligram per deciliter | Standard Deviation 18.14 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 22 | -68.80 milligram per deciliter | Standard Deviation 32.78 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 50 | -9.00 milligram per deciliter | Standard Deviation 17.87 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 6 | -31.20 milligram per deciliter | Standard Deviation 20.31 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 57 | 6.50 milligram per deciliter | Standard Deviation 32.76 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 29 | -69.00 milligram per deciliter | Standard Deviation 35.01 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 64 | 12.10 milligram per deciliter | Standard Deviation 20.13 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 5 | 12.60 milligram per deciliter | Standard Deviation 21.9 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 64 | 12.70 milligram per deciliter | Standard Deviation 35.12 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 5 | -19.40 milligram per deciliter | Standard Deviation 15.16 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 6 | -35.90 milligram per deciliter | Standard Deviation 22.27 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 7 | -47.60 milligram per deciliter | Standard Deviation 24.04 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 15 | -30.10 milligram per deciliter | Standard Deviation 36.18 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 22 | 4.70 milligram per deciliter | Standard Deviation 40.14 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 29 | 7.90 milligram per deciliter | Standard Deviation 39.76 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 36 | 3.50 milligram per deciliter | Standard Deviation 41.05 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 43 | 6.60 milligram per deciliter | Standard Deviation 38.85 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 50 | 3.10 milligram per deciliter | Standard Deviation 37.89 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Non High-density Lipoprotein-Cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 57 | 14.30 milligram per deciliter | Standard Deviation 39.36 |
Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Time frame: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 15 | -58.00 milligram per deciliter | Standard Deviation 39.02 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 36 | -56.30 milligram per deciliter | Standard Deviation 28.61 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 7 | -37.30 milligram per deciliter | Standard Deviation 25.72 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 43 | -28.90 milligram per deciliter | Standard Deviation 19.61 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 22 | -61.30 milligram per deciliter | Standard Deviation 34.91 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 50 | -6.30 milligram per deciliter | Standard Deviation 18.51 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 6 | -33.30 milligram per deciliter | Standard Deviation 19.04 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 57 | 9.30 milligram per deciliter | Standard Deviation 31.92 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 29 | -62.60 milligram per deciliter | Standard Deviation 32.81 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 64 | 12.10 milligram per deciliter | Standard Deviation 23 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 5 | -13.90 milligram per deciliter | Standard Deviation 19.48 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 64 | 15.10 milligram per deciliter | Standard Deviation 31.48 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 5 | -21.60 milligram per deciliter | Standard Deviation 15.04 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 6 | -38.30 milligram per deciliter | Standard Deviation 18.03 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 7 | -50.00 milligram per deciliter | Standard Deviation 20.5 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 15 | -24.30 milligram per deciliter | Standard Deviation 38.29 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 22 | 7.50 milligram per deciliter | Standard Deviation 38.05 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 29 | 8.40 milligram per deciliter | Standard Deviation 36.28 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 36 | 5.30 milligram per deciliter | Standard Deviation 36.43 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 43 | 9.80 milligram per deciliter | Standard Deviation 38.4 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 50 | 4.80 milligram per deciliter | Standard Deviation 34.39 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 57 | 18.50 milligram per deciliter | Standard Deviation 34.69 |
Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Time frame: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 15 | -19.60 milligram per deciliter | Standard Deviation 41.4 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 36 | -22.20 milligram per deciliter | Standard Deviation 54.24 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 7 | 8.10 milligram per deciliter | Standard Deviation 38.09 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 43 | -13.10 milligram per deciliter | Standard Deviation 42.48 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 22 | -4.30 milligram per deciliter | Standard Deviation 45.63 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 50 | 11.60 milligram per deciliter | Standard Deviation 57.86 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 6 | 11.70 milligram per deciliter | Standard Deviation 24.23 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 57 | 26.20 milligram per deciliter | Standard Deviation 63.42 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 29 | -17.40 milligram per deciliter | Standard Deviation 21.51 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 64 | 29.60 milligram per deciliter | Standard Deviation 53.23 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 5 | 9.20 milligram per deciliter | Standard Deviation 61.82 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 64 | 3.10 milligram per deciliter | Standard Deviation 31.78 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 5 | -15.80 milligram per deciliter | Standard Deviation 38.46 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 6 | -9.90 milligram per deciliter | Standard Deviation 31.22 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 7 | -6.90 milligram per deciliter | Standard Deviation 44.25 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 15 | -21.10 milligram per deciliter | Standard Deviation 56.39 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 22 | 13.60 milligram per deciliter | Standard Deviation 52.71 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 29 | -8.20 milligram per deciliter | Standard Deviation 60.64 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 36 | -0.30 milligram per deciliter | Standard Deviation 70.24 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 43 | -10.90 milligram per deciliter | Standard Deviation 64.52 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 50 | -4.90 milligram per deciliter | Standard Deviation 79.62 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Change From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Change at Day 57 | 16.50 milligram per deciliter | Standard Deviation 56.65 |
Duration of Low Density Lipoprotein (LDL) Lowering Effects
In this outcome measure duration of the lipid-lowering effects was reported. Lipid lowering was defined as decrease in LDL-C levels by greater than or equal to 15 percent.
Time frame: Day 4 to Day 64
Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Duration of Low Density Lipoprotein (LDL) Lowering Effects | 48.5 days | Full Range 16.36 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Duration of Low Density Lipoprotein (LDL) Lowering Effects | 18.0 days | Full Range 15.68 |
Number of Participants With Positive Anti-drug Antibodies (ADA)
Human serum ADA samples of participants who received PF-04950615 (RN316) were analyzed for the presence of anti-PF-04950615 (RN316) antibodies. Results with titer value \>=4.32 nanogram per milliliter of anti-PF-04950615 antibodies were counted as positive. Number of participants with presence of anti-PF-04950615 antibodies were reported in this outcome measure.
Time frame: Day 1 up to Day 64
Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Positive Anti-drug Antibodies (ADA) | 4 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Positive Anti-drug Antibodies (ADA) | 0 Participants |
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) Parameters
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. ECG parameters RR interval, PR interval, QRS complex, QT interval, \[Bazett's Correction\], QTcF interval \[Fridericia's Correction\] were assessed to identify systemic AEs. AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported. CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. Categories with at least 1 participant were reported.
Time frame: Day 1 up to Day 64
Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) Parameters | AEs (All causalities) | 0 Participants |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) Parameters | Treatment related AEs | 0 Participants |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) Parameters | Grade 1 AEs: (All causalities) | 0 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) Parameters | AEs (All causalities) | 1 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) Parameters | Treatment related AEs | 0 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) Parameters | Grade 1 AEs: (All causalities) | 1 Participants |
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters
Laboratory parameters alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, gamma glutamyl transferase, lactate dehydrogenase, albumin, hemoglobin, protein, amylase, creatine kinase, lipase, basophils, eosinophils, lymphocytes, monocytes, neutrophils, platelets, white blood cells, bicarbonate, chloride, potassium, sodium, bilirubin, blood urea nitrogen, c-reactive protein , calcium, creatinine, direct bilirubin, glucose, magnesium, phosphate, uric acid, hematocrit, partial thromboplastin time , prothrombin time, red blood cells , urine pH, urine specific gravity were assessed to identify systemic AEs. AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported. Same participant may be reported in more than 1 CTCAE severity grade. Categories with at least 1 participant were reported.
Time frame: Day 1 up to Day 64
Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters | AEs (All causalities) | 2 Participants |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters | Treatment related AEs | 2 Participants |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters | Grade 1 AEs: (All causalities) | 0 Participants |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters | Grade 1 AEs: (Treatment related) | 2 Participants |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters | Grade 2 AEs: (Treatment related) | 1 Participants |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters | Grade 3 AEs: (Treatment related) | 1 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters | Grade 2 AEs: (Treatment related) | 0 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters | AEs (All causalities) | 1 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters | Grade 1 AEs: (Treatment related) | 0 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters | Treatment related AEs | 0 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters | Grade 3 AEs: (Treatment related) | 0 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory Parameters | Grade 1 AEs: (All causalities) | 1 Participants |
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Physical Examination
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. Complete physical examination was conducted to assess skin, ears, throat, cardiac, respiratory, gastrointestinal, and musculoskeletal systems for systemic AEs.
Time frame: Day 1 up to Day 64
Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Physical Examination | 0 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Physical Examination | 0 Participants |
Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. Vital sign parameters body temperature, blood pressure and heart rate were assessed to identify systemic adverse events. AEs (all causalities), treatment related AEs and CTCAE severity grades for AEs were reported. CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. Categories with at least 1 participant were reported
Time frame: Day 1 up to Day 64
Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs | AEs (All causalities) | 0 Participants |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs | Treatment related AEs | 0 Participants |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs | Grade 1 AEs: (All causalities) | 0 Participants |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs | Grade 2 AEs: (All causalities) | 0 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs | Grade 2 AEs: (All causalities) | 1 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs | AEs (All causalities) | 2 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs | Grade 1 AEs: (All causalities) | 1 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital Signs | Treatment related AEs | 0 Participants |
Number of Participants With Toxicity or Intolerable Dose Criteria
Toxicity criteria included any of the following: serious adverse event; increased liver transaminases (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\]: increased to greater than \[\>\] 5\*upper limit of normal reference range \[ULN\]); increased bilirubin (in absence of ALT or AST elevations, common terminology criteria for adverse events \[CTCAE\] greater than or equal to \[\>=\] Grade 2); pancreatitis, increased serum creatinine (CTCAE \>= Grade 2); creatine kinase, hyperglycemia or hypoglycemia, diarrhea or enteritis or nausea (CTCAE \>= Grade 3); decreased platelet count (less than \[\<\] 100000 per microliter); prolongation of QT interval with Fridericia's Correction (QTcF) (QTcF \>500 millisecond \[msec\] \[CTCAE \>= Grade 3\] or increase from baseline of \>=60 msec) and other considered appropriate by investigator. CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event.
Time frame: Day 1 up to Day 64
Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Toxicity or Intolerable Dose Criteria | 0 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Toxicity or Intolerable Dose Criteria | 0 Participants |
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a 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-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. Adverse events included both serious and non-serious adverse events.
Time frame: Day 1 up to Day 64
Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 12 Participants |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 1 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 11 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
Number of Participants With Treatment-Emergent Adverse Events by Severity
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study drug and up to 64 days that were absent before treatment or that worsened relative to pretreatment state. AEs were assessed for severity by CTCAE Grade 4.0: Grade 1= mild; Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening consequences and Grade 5= death related to adverse event. Categories with at least 1 participant were reported
Time frame: Day 1 up to Day 64
Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Treatment-Emergent Adverse Events by Severity | Grade 1 AEs | 5 Participants |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Treatment-Emergent Adverse Events by Severity | Grade 2 AEs | 4 Participants |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Treatment-Emergent Adverse Events by Severity | Grade 3 AEs | 2 Participants |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Treatment-Emergent Adverse Events by Severity | Unknown | 1 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Treatment-Emergent Adverse Events by Severity | Unknown | 0 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Treatment-Emergent Adverse Events by Severity | Grade 1 AEs | 8 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Treatment-Emergent Adverse Events by Severity | Grade 3 AEs | 0 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Treatment-Emergent Adverse Events by Severity | Grade 2 AEs | 3 Participants |
Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. 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.
Time frame: Day 1 up to Day 64
Population: Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 6 Participants |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | SAEs | 0 Participants |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Number of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs) | AEs | 0 Participants |
Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.
Time frame: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 15 | 5.10 percent change | Standard Deviation 6.31 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 36 | 7.30 percent change | Standard Deviation 7.64 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 7 | 2.90 percent change | Standard Deviation 7.14 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 43 | 5.80 percent change | Standard Deviation 7.73 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 22 | 4.40 percent change | Standard Deviation 8.27 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 50 | 4.50 percent change | Standard Deviation 5.77 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 6 | -1.00 percent change | Standard Deviation 7.27 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 57 | 3.40 percent change | Standard Deviation 8.71 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 29 | 5.20 percent change | Standard Deviation 9.94 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 64 | 0.80 percent change | Standard Deviation 7.48 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 5 | -1.90 percent change | Standard Deviation 7.48 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 64 | 16.90 percent change | Standard Deviation 14.18 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 5 | 2.10 percent change | Standard Deviation 6.61 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 6 | -4.20 percent change | Standard Deviation 6.8 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 7 | -0.80 percent change | Standard Deviation 7.97 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 15 | 9.10 percent change | Standard Deviation 12.52 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 22 | 11.50 percent change | Standard Deviation 11.39 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 29 | 7.80 percent change | Standard Deviation 17.55 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 36 | 8.80 percent change | Standard Deviation 11.09 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 43 | 11.60 percent change | Standard Deviation 12.44 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 50 | 3.50 percent change | Standard Deviation 16.45 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 57 | 18.80 percent change | Standard Deviation 7.84 |
Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.
Time frame: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 15 | -48.60 percent change | Standard Deviation 13.82 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 36 | -48.80 percent change | Standard Deviation 9.97 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 7 | -33.80 percent change | Standard Deviation 12.27 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 43 | -33.80 percent change | Standard Deviation 8.98 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 22 | -51.50 percent change | Standard Deviation 11.04 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 50 | -13.70 percent change | Standard Deviation 13.7 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 6 | -26.90 percent change | Standard Deviation 11.01 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 57 | -5.80 percent change | Standard Deviation 18.03 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 29 | -53.70 percent change | Standard Deviation 10.37 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 64 | 3.00 percent change | Standard Deviation 12.82 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 5 | -13.50 percent change | Standard Deviation 9.25 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 64 | 11.50 percent change | Standard Deviation 25.5 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 5 | -17.10 percent change | Standard Deviation 11.22 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 6 | -31.10 percent change | Standard Deviation 13.84 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 7 | -36.10 percent change | Standard Deviation 15.68 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 15 | -24.80 percent change | Standard Deviation 18.18 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 22 | -0.70 percent change | Standard Deviation 19.21 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 29 | 3.80 percent change | Standard Deviation 26.31 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 36 | 1.50 percent change | Standard Deviation 22.64 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 43 | 2.70 percent change | Standard Deviation 18.81 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 50 | -1.50 percent change | Standard Deviation 21.38 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 57 | 9.40 percent change | Standard Deviation 19.89 |
Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Time frame: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 15 | 11.10 percent change | Standard Deviation 19.48 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 36 | 7.80 percent change | Standard Deviation 11.5 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 7 | -1.10 percent change | Standard Deviation 9.29 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 43 | 14.50 percent change | Standard Deviation 15.67 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 22 | 13.90 percent change | Standard Deviation 9.65 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 50 | 6.10 percent change | Standard Deviation 13.89 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 6 | -3.60 percent change | Standard Deviation 8.24 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 57 | 6.10 percent change | Standard Deviation 11.93 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 29 | 14.00 percent change | Standard Deviation 15.04 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 64 | 0.50 percent change | Standard Deviation 12.37 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 5 | -2.50 percent change | Standard Deviation 11.27 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 64 | 8.20 percent change | Standard Deviation 12.15 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 5 | -1.70 percent change | Standard Deviation 10.93 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 6 | -0.90 percent change | Standard Deviation 18.31 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 7 | -0.90 percent change | Standard Deviation 18.01 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 15 | 13.40 percent change | Standard Deviation 12.4 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 22 | 8.00 percent change | Standard Deviation 11.23 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 29 | 3.00 percent change | Standard Deviation 11.72 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 36 | 7.50 percent change | Standard Deviation 17.15 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 43 | 8.70 percent change | Standard Deviation 8.79 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 50 | 6.70 percent change | Standard Deviation 14.2 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 57 | 14.00 percent change | Standard Deviation 19.37 |
Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Time frame: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 15 | -61.10 percent change | Standard Deviation 31.98 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 36 | -68.20 percent change | Standard Deviation 15.59 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 7 | -38.90 percent change | Standard Deviation 24.15 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 43 | -41.80 percent change | Standard Deviation 18.87 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 22 | -71.60 percent change | Standard Deviation 21.89 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 50 | -14.70 percent change | Standard Deviation 17.1 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 6 | -33.80 percent change | Standard Deviation 20.61 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 57 | 1.40 percent change | Standard Deviation 24.8 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 29 | -68.70 percent change | Standard Deviation 22.2 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 64 | 13.40 percent change | Standard Deviation 31.22 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 5 | -15.70 percent change | Standard Deviation 23.36 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 64 | 25.60 percent change | Standard Deviation 42.94 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 5 | -27.30 percent change | Standard Deviation 23.6 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 6 | -47.00 percent change | Standard Deviation 30.57 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 7 | -65.10 percent change | Standard Deviation 31.82 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 15 | -33.30 percent change | Standard Deviation 29.8 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 22 | 11.40 percent change | Standard Deviation 46.23 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 29 | 21.60 percent change | Standard Deviation 46.26 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 36 | 14.90 percent change | Standard Deviation 36.9 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 43 | 19.70 percent change | Standard Deviation 38.86 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 50 | 13.70 percent change | Standard Deviation 37.36 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 57 | 23.60 percent change | Standard Deviation 47.93 |
Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Time frame: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 15 | -56.00 percent change | Standard Deviation 26.05 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 36 | -57.30 percent change | Standard Deviation 16.6 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 7 | -32.80 percent change | Standard Deviation 18.81 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 43 | -35.70 percent change | Standard Deviation 16.64 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 22 | -63.90 percent change | Standard Deviation 18 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 50 | -9.40 percent change | Standard Deviation 16.55 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 6 | -28.70 percent change | Standard Deviation 16.69 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 57 | 7.80 percent change | Standard Deviation 26.93 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 29 | -63.90 percent change | Standard Deviation 17.86 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 64 | 15.60 percent change | Standard Deviation 20.3 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 5 | -9.90 percent change | Standard Deviation 20.47 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 64 | 21.20 percent change | Standard Deviation 35.27 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 5 | -20.30 percent change | Standard Deviation 15.38 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 6 | -37.60 percent change | Standard Deviation 26.74 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 7 | -50.00 percent change | Standard Deviation 26.78 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 15 | -25.40 percent change | Standard Deviation 26.16 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 22 | 14.70 percent change | Standard Deviation 40.72 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 29 | 16.10 percent change | Standard Deviation 40.69 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 36 | 14.00 percent change | Standard Deviation 36.59 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 43 | 14.30 percent change | Standard Deviation 35.8 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 50 | 12.90 percent change | Standard Deviation 38.29 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Non-High-density Lipoprotein-cholesterol (Non-HDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 57 | 23.80 percent change | Standard Deviation 44.36 |
Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.
Time frame: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 15 | -6.10 percent change | Standard Deviation 41.62 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 36 | -15.90 percent change | Standard Deviation 32.23 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 7 | 5.00 percent change | Standard Deviation 21.2 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 43 | -7.90 percent change | Standard Deviation 25.94 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 22 | -2.20 percent change | Standard Deviation 30.73 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 50 | 12.60 percent change | Standard Deviation 42.61 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 6 | 7.40 percent change | Standard Deviation 20.29 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 57 | 20.10 percent change | Standard Deviation 45.52 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 29 | -14.60 percent change | Standard Deviation 20.02 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 64 | 28.60 percent change | Standard Deviation 42.51 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 5 | 11.20 percent change | Standard Deviation 65.46 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 64 | 7.60 percent change | Standard Deviation 30.24 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 5 | -3.30 percent change | Standard Deviation 24.88 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 6 | 1.10 percent change | Standard Deviation 22.05 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 7 | 0.50 percent change | Standard Deviation 27.67 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 15 | -1.40 percent change | Standard Deviation 35.76 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 22 | 19.90 percent change | Standard Deviation 42.17 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 29 | 0.80 percent change | Standard Deviation 34.11 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 36 | 12.20 percent change | Standard Deviation 45.69 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 43 | 3.20 percent change | Standard Deviation 33.05 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 50 | 12.10 percent change | Standard Deviation 49.12 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 57 | 22.20 percent change | Standard Deviation 41.65 |
Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.
Time frame: Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64
Population: Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. Here, 'Number Participants Analyzed' is signifying those participants who were evaluable for particular category for each arm group respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 29 | -39.40 percent change | Standard Deviation 14.5 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 6 | -21.20 percent change | Standard Deviation 10.16 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 36 | -36.30 percent change | Standard Deviation 14 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 15 | -35.40 percent change | Standard Deviation 19.65 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 43 | -18.90 percent change | Standard Deviation 10.34 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 5 | -8.30 percent change | Standard Deviation 11.81 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 50 | -3.70 percent change | Standard Deviation 11.17 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 22 | -38.40 percent change | Standard Deviation 16.7 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 57 | 7.50 percent change | Standard Deviation 19.31 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 64 | 10.10 percent change | Standard Deviation 14.86 |
| PF-04950615 (RN316) 4 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 7 | -23.10 percent change | Standard Deviation 14.16 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 64 | 12.50 percent change | Standard Deviation 18.07 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 5 | -14.60 percent change | Standard Deviation 8.87 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 6 | -26.20 percent change | Standard Deviation 10.56 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 7 | -34.10 percent change | Standard Deviation 11.39 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 15 | -14.40 percent change | Standard Deviation 18.89 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 22 | 7.40 percent change | Standard Deviation 21.95 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 29 | 7.40 percent change | Standard Deviation 19.86 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 36 | 7.00 percent change | Standard Deviation 21.5 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 43 | 9.00 percent change | Standard Deviation 21.22 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 50 | 6.00 percent change | Standard Deviation 19.62 |
| PF-04950615 (RN316) 0.5 mg/kg + Atorvastatin | Percent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | Percent change at Day 57 | 14.30 percent change | Standard Deviation 20.05 |