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Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of PF-04950615 (RN316) In Combination With Atorvastatin

A Phase 1 Study Evaluating The Pharmacokinetics And Pharmacodynamics Of Rn316 In Combination With Atorvastatin In Hypercholesterolemic Subjects

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01163851
Enrollment
25
Registered
2010-07-16
Start date
2010-07-31
Completion date
2011-04-30
Last updated
2018-03-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia, Hypercholesterolemia

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

BIOLOGICAL4 mg/kg

RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.

BIOLOGICAL0.5 mg/kg

RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-049506150 (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-049506150 (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-049506150 (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-049506150 (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 64Plasma decay half-life is the time measured for the plasma concentration of PF-04950615 to decrease by one half.
Systemic Clearance (CL) of PF-049506150 (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 64CL 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-049506150 (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 64Volume 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-049506150 (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 Atorvastatin0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4AUCtau 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 Atorvastatin0 (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 Atorvastatin0 (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 Atorvastatin0 (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 7Plasma decay half-life is the time measured for the plasma concentration of atorvastatin to decrease by one half.
Apparent Oral Clearance (CL/F) of Atorvastatin0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4Clearance 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 Atorvastatin0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4Volume 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

MeasureTime frameDescription
Percent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 (RN316) administration.
Duration of Low Density Lipoprotein (LDL) Lowering EffectsDay 4 to Day 64In 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 CriteriaDay 1 up to Day 64Toxicity 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 64An 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 SeverityDay 1 up to Day 64An 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 64Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Baseline 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 ExaminationDay 1 up to Day 64An 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 SignsDay 1 up to Day 64An 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) ParametersDay 1 up to Day 64An 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 ParametersDay 1 up to Day 64Laboratory 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 64Human 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 64An 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 64Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Baseline 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 64Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Baseline 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 64Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Baseline 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 64Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Baseline 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 64Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Baseline 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 64Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Baseline 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 64Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Baseline 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 64Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Baseline 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 64Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Baseline 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 64Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Baseline 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 64Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Baseline 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 64Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
Total24

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyEnrolled but not treated10
Overall StudySite Closure01

Baseline characteristics

CharacteristicPF-04950615 (RN316) 4 mg/kg + AtorvastatinPF-04950615 (RN316) 0.5 mg/kg + AtorvastatinTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
3 Participants3 Participants6 Participants
Age, Categorical
Between 18 and 65 years
9 Participants9 Participants18 Participants
Sex: Female, Male
Female
7 Participants5 Participants12 Participants
Sex: Female, Male
Male
5 Participants7 Participants12 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
12 / 1211 / 12
serious
Total, serious adverse events
1 / 120 / 12

Outcome results

Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinApparent Oral Clearance (CL/F) of Atorvastatin557.50 liter per hourStandard Deviation 238.33
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinApparent Oral Clearance (CL/F) of Atorvastatin448.70 liter per hourStandard Deviation 196.91
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinApparent Volume of Distribution (Vz/F) of Atorvastatin3950 literStandard Deviation 1952.8
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinApparent Volume of Distribution (Vz/F) of Atorvastatin3353 literStandard Deviation 1960.8
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinArea Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Atorvastatin71.73 nanogram*hour per milliliterStandard Deviation 32.22
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinArea Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Atorvastatin89.17 nanogram*hour per milliliterStandard Deviation 33.25
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinArea Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of PF-0495061517960000 nanogram*hour per milliliterStandard Deviation 2828500
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinArea Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of PF-049506151094000 nanogram*hour per milliliterStandard Deviation 123640
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinArea Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-0495061517950000 nanogram*hour per milliliterStandard Deviation 2779600
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinArea Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615933800 nanogram*hour per milliliterStandard Deviation 376350
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinMaximum Observed Plasma Concentration (Cmax) of Atorvastatin15.79 nanogram per milliliterStandard Deviation 8.81
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinMaximum Observed Plasma Concentration (Cmax) of Atorvastatin20.68 nanogram per milliliterStandard Deviation 10.58
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinMaximum Observed Plasma Concentration (Cmax) of PF-04950615105000 nanogram per milliliterStandard Deviation 16587
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinMaximum Observed Plasma Concentration (Cmax) of PF-0495061514030 nanogram per milliliterStandard Deviation 1680
Primary

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.

ArmMeasureValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPlasma Decay Half-Life (t1/2) of Atorvastatin5.12 hourStandard Deviation 1.38
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPlasma Decay Half-Life (t1/2) of Atorvastatin5.09 hourStandard Deviation 0.74
Primary

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.

ArmMeasureValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPlasma Decay Half-Life (t1/2) of PF-04950615157.50 hourStandard Deviation 33.22
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPlasma Decay Half-Life (t1/2) of PF-0495061561.00 hourStandard Deviation 8.89
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinSystemic Clearance (CL) of PF-049506150.0185 liter per hourStandard Deviation 0.0041
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinSystemic Clearance (CL) of PF-049506150.0392 liter per hourStandard Deviation 0.0031
Primary

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.

ArmMeasureValue (MEDIAN)
PF-04950615 (RN316) 4 mg/kg + AtorvastatinTime to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin1.16 hour
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinTime to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin1.00 hour
Primary

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.

ArmMeasureValue (MEDIAN)
PF-04950615 (RN316) 4 mg/kg + AtorvastatinTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-049506152.59 hour
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinTime to Reach Maximum Observed Plasma Concentration (Tmax) of PF-049506154.00 hour
Primary

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.

ArmMeasureValue (GEOMETRIC_MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinVolume of Distribution at Steady State (Vss) of PF-049506154.248 literStandard Deviation 1.099
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinVolume of Distribution at Steady State (Vss) of PF-049506153.436 literStandard Deviation 0.583
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 156.80 milligram per deciliterStandard Deviation 8.3
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 3610.30 milligram per deciliterStandard Deviation 10.87
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 73.40 milligram per deciliterStandard Deviation 10.93
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 437.80 milligram per deciliterStandard Deviation 10.73
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 225.70 milligram per deciliterStandard Deviation 11.13
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 506.50 milligram per deciliterStandard Deviation 8.64
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6-1.70 milligram per deciliterStandard Deviation 10.79
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 574.40 milligram per deciliterStandard Deviation 11.77
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 297.50 milligram per deciliterStandard Deviation 13.43
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 640.50 milligram per deciliterStandard Deviation 10.82
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5-3.00 milligram per deciliterStandard Deviation 10.95
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6422.10 milligram per deciliterStandard Deviation 19.44
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 52.80 milligram per deciliterStandard Deviation 8.7
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6-5.60 milligram per deciliterStandard Deviation 8.07
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 7-1.50 milligram per deciliterStandard Deviation 9.22
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 1512.10 milligram per deciliterStandard Deviation 18.48
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 2216.10 milligram per deciliterStandard Deviation 18.71
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 2911.40 milligram per deciliterStandard Deviation 27.34
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 3611.50 milligram per deciliterStandard Deviation 15.09
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 4314.90 milligram per deciliterStandard Deviation 15.96
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 505.20 milligram per deciliterStandard Deviation 22.03
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein A1 (ApoA1) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5724.50 milligram per deciliterStandard Deviation 12.51
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 15-41.90 milligram per deciliterStandard Deviation 19.41
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 36-41.10 milligram per deciliterStandard Deviation 15.09
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 7-28.30 milligram per deciliterStandard Deviation 12.57
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 43-27.30 milligram per deciliterStandard Deviation 7.48
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 22-44.00 milligram per deciliterStandard Deviation 17.67
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 50-10.40 milligram per deciliterStandard Deviation 10.53
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6-22.10 milligram per deciliterStandard Deviation 10.05
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 57-5.10 milligram per deciliterStandard Deviation 15.7
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 29-45.80 milligram per deciliterStandard Deviation 17.61
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 642.30 milligram per deciliterStandard Deviation 10.7
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5-10.90 milligram per deciliterStandard Deviation 7.48
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 645.80 milligram per deciliterStandard Deviation 20.99
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5-13.10 milligram per deciliterStandard Deviation 8.49
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6-24.90 milligram per deciliterStandard Deviation 12.88
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 7-29.50 milligram per deciliterStandard Deviation 16.75
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 15-21.70 milligram per deciliterStandard Deviation 19.84
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 22-3.30 milligram per deciliterStandard Deviation 18.78
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 29-1.10 milligram per deciliterStandard Deviation 23.99
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 36-2.70 milligram per deciliterStandard Deviation 19.76
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 43-0.60 milligram per deciliterStandard Deviation 18.47
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 50-4.60 milligram per deciliterStandard Deviation 20.74
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Apolipoprotein B (ApoB) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 574.70 milligram per deciliterStandard Deviation 15.51
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 154.50 milligram per deciliterStandard Deviation 8.01
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 363.80 milligram per deciliterStandard Deviation 5.52
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 7-0.90 milligram per deciliterStandard Deviation 4.41
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 436.10 milligram per deciliterStandard Deviation 6.59
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 226.70 milligram per deciliterStandard Deviation 4.65
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 502.80 milligram per deciliterStandard Deviation 6.27
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6-2.10 milligram per deciliterStandard Deviation 4.16
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 572.70 milligram per deciliterStandard Deviation 5.26
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 296.50 milligram per deciliterStandard Deviation 6.53
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 64-0.0 milligram per deciliterStandard Deviation 6.02
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5-1.30 milligram per deciliterStandard Deviation 5.6
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 642.40 milligram per deciliterStandard Deviation 7.95
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5-2.20 milligram per deciliterStandard Deviation 7.95
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6-2.40 milligram per deciliterStandard Deviation 11.71
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 7-2.40 milligram per deciliterStandard Deviation 12.63
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 155.90 milligram per deciliterStandard Deviation 5.13
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 222.80 milligram per deciliterStandard Deviation 5.41
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 290.50 milligram per deciliterStandard Deviation 5.99
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 361.90 milligram per deciliterStandard Deviation 8.2
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 433.10 milligram per deciliterStandard Deviation 5.39
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 501.70 milligram per deciliterStandard Deviation 7.71
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 574.20 milligram per deciliterStandard Deviation 9.22
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 15-52.40 milligram per deciliterStandard Deviation 35.31
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 36-55.50 milligram per deciliterStandard Deviation 23.64
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 7-33.30 milligram per deciliterStandard Deviation 22.42
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 43-32.30 milligram per deciliterStandard Deviation 15.64
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 22-57.20 milligram per deciliterStandard Deviation 30.71
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 50-11.40 milligram per deciliterStandard Deviation 13.27
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6-28.50 milligram per deciliterStandard Deviation 17.22
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 57-1.50 milligram per deciliterStandard Deviation 22.25
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 29-56.90 milligram per deciliterStandard Deviation 35.21
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 646.20 milligram per deciliterStandard Deviation 24.62
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5-14.30 milligram per deciliterStandard Deviation 17.79
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6412.10 milligram per deciliterStandard Deviation 33.42
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5-16.2 milligram per deciliterStandard Deviation 11.56
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6-34.00 milligram per deciliterStandard Deviation 19.13
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 7-47.20 milligram per deciliterStandard Deviation 20.66
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 15-25.90 milligram per deciliterStandard Deviation 31.94
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 222.10 milligram per deciliterStandard Deviation 36.01
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 299.40 milligram per deciliterStandard Deviation 33.12
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 363.40 milligram per deciliterStandard Deviation 33.09
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 438.80 milligram per deciliterStandard Deviation 34.18
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 504.10 milligram per deciliterStandard Deviation 29.02
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5710.90 milligram per deciliterStandard Deviation 35.79
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange 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 64Change at Day 15-62.50 milligram per deciliterStandard Deviation 39.4
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange 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 64Change at Day 36-60.00 milligram per deciliterStandard Deviation 29.56
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange 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 64Change at Day 7-36.40 milligram per deciliterStandard Deviation 24.5
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange 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 64Change at Day 43-35.00 milligram per deciliterStandard Deviation 18.14
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange 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 64Change at Day 22-68.80 milligram per deciliterStandard Deviation 32.78
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange 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 64Change at Day 50-9.00 milligram per deciliterStandard Deviation 17.87
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange 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 64Change at Day 6-31.20 milligram per deciliterStandard Deviation 20.31
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange 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 64Change at Day 576.50 milligram per deciliterStandard Deviation 32.76
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange 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 64Change at Day 29-69.00 milligram per deciliterStandard Deviation 35.01
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange 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 64Change at Day 6412.10 milligram per deciliterStandard Deviation 20.13
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange 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 64Change at Day 512.60 milligram per deciliterStandard Deviation 21.9
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange 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 64Change at Day 6412.70 milligram per deciliterStandard Deviation 35.12
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange 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 64Change at Day 5-19.40 milligram per deciliterStandard Deviation 15.16
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange 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 64Change at Day 6-35.90 milligram per deciliterStandard Deviation 22.27
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange 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 64Change at Day 7-47.60 milligram per deciliterStandard Deviation 24.04
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange 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 64Change at Day 15-30.10 milligram per deciliterStandard Deviation 36.18
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange 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 64Change at Day 224.70 milligram per deciliterStandard Deviation 40.14
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange 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 64Change at Day 297.90 milligram per deciliterStandard Deviation 39.76
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange 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 64Change at Day 363.50 milligram per deciliterStandard Deviation 41.05
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange 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 64Change at Day 436.60 milligram per deciliterStandard Deviation 38.85
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange 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 64Change at Day 503.10 milligram per deciliterStandard Deviation 37.89
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange 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 64Change at Day 5714.30 milligram per deciliterStandard Deviation 39.36
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 15-58.00 milligram per deciliterStandard Deviation 39.02
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 36-56.30 milligram per deciliterStandard Deviation 28.61
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 7-37.30 milligram per deciliterStandard Deviation 25.72
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 43-28.90 milligram per deciliterStandard Deviation 19.61
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 22-61.30 milligram per deciliterStandard Deviation 34.91
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 50-6.30 milligram per deciliterStandard Deviation 18.51
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6-33.30 milligram per deciliterStandard Deviation 19.04
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 579.30 milligram per deciliterStandard Deviation 31.92
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 29-62.60 milligram per deciliterStandard Deviation 32.81
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6412.10 milligram per deciliterStandard Deviation 23
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5-13.90 milligram per deciliterStandard Deviation 19.48
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6415.10 milligram per deciliterStandard Deviation 31.48
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5-21.60 milligram per deciliterStandard Deviation 15.04
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6-38.30 milligram per deciliterStandard Deviation 18.03
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 7-50.00 milligram per deciliterStandard Deviation 20.5
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 15-24.30 milligram per deciliterStandard Deviation 38.29
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 227.50 milligram per deciliterStandard Deviation 38.05
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 298.40 milligram per deciliterStandard Deviation 36.28
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 365.30 milligram per deciliterStandard Deviation 36.43
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 439.80 milligram per deciliterStandard Deviation 38.4
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 504.80 milligram per deciliterStandard Deviation 34.39
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5718.50 milligram per deciliterStandard Deviation 34.69
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 15-19.60 milligram per deciliterStandard Deviation 41.4
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 36-22.20 milligram per deciliterStandard Deviation 54.24
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 78.10 milligram per deciliterStandard Deviation 38.09
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 43-13.10 milligram per deciliterStandard Deviation 42.48
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 22-4.30 milligram per deciliterStandard Deviation 45.63
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5011.60 milligram per deciliterStandard Deviation 57.86
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 611.70 milligram per deciliterStandard Deviation 24.23
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5726.20 milligram per deciliterStandard Deviation 63.42
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 29-17.40 milligram per deciliterStandard Deviation 21.51
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6429.60 milligram per deciliterStandard Deviation 53.23
PF-04950615 (RN316) 4 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 59.20 milligram per deciliterStandard Deviation 61.82
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 643.10 milligram per deciliterStandard Deviation 31.78
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5-15.80 milligram per deciliterStandard Deviation 38.46
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 6-9.90 milligram per deciliterStandard Deviation 31.22
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 7-6.90 milligram per deciliterStandard Deviation 44.25
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 15-21.10 milligram per deciliterStandard Deviation 56.39
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 2213.60 milligram per deciliterStandard Deviation 52.71
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 29-8.20 milligram per deciliterStandard Deviation 60.64
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 36-0.30 milligram per deciliterStandard Deviation 70.24
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 43-10.90 milligram per deciliterStandard Deviation 64.52
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 50-4.90 milligram per deciliterStandard Deviation 79.62
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinChange From Baseline in Fasting Triglycerides at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Change at Day 5716.50 milligram per deciliterStandard Deviation 56.65
Secondary

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.

ArmMeasureValue (MEDIAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinDuration of Low Density Lipoprotein (LDL) Lowering Effects48.5 daysFull Range 16.36
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinDuration of Low Density Lipoprotein (LDL) Lowering Effects18.0 daysFull Range 15.68
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Positive Anti-drug Antibodies (ADA)4 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Positive Anti-drug Antibodies (ADA)0 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) ParametersAEs (All causalities)0 Participants
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) ParametersTreatment related AEs0 Participants
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) ParametersGrade 1 AEs: (All causalities)0 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) ParametersAEs (All causalities)1 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) ParametersTreatment related AEs0 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Electrocardiogram (ECG) ParametersGrade 1 AEs: (All causalities)1 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory ParametersAEs (All causalities)2 Participants
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory ParametersTreatment related AEs2 Participants
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory ParametersGrade 1 AEs: (All causalities)0 Participants
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory ParametersGrade 1 AEs: (Treatment related)2 Participants
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory ParametersGrade 2 AEs: (Treatment related)1 Participants
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory ParametersGrade 3 AEs: (Treatment related)1 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory ParametersGrade 2 AEs: (Treatment related)0 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory ParametersAEs (All causalities)1 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory ParametersGrade 1 AEs: (Treatment related)0 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory ParametersTreatment related AEs0 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory ParametersGrade 3 AEs: (Treatment related)0 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Laboratory ParametersGrade 1 AEs: (All causalities)1 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Physical Examination0 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Physical Examination0 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital SignsAEs (All causalities)0 Participants
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital SignsTreatment related AEs0 Participants
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital SignsGrade 1 AEs: (All causalities)0 Participants
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital SignsGrade 2 AEs: (All causalities)0 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital SignsGrade 2 AEs: (All causalities)1 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital SignsAEs (All causalities)2 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital SignsGrade 1 AEs: (All causalities)1 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Systemic Treatment Emergent Adverse Events Identified by Vital SignsTreatment related AEs0 Participants
Secondary

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Toxicity or Intolerable Dose Criteria0 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Toxicity or Intolerable Dose Criteria0 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs12 Participants
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs1 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs11 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs0 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Treatment-Emergent Adverse Events by SeverityGrade 1 AEs5 Participants
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Treatment-Emergent Adverse Events by SeverityGrade 2 AEs4 Participants
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Treatment-Emergent Adverse Events by SeverityGrade 3 AEs2 Participants
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Treatment-Emergent Adverse Events by SeverityUnknown1 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Treatment-Emergent Adverse Events by SeverityUnknown0 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Treatment-Emergent Adverse Events by SeverityGrade 1 AEs8 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Treatment-Emergent Adverse Events by SeverityGrade 3 AEs0 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Treatment-Emergent Adverse Events by SeverityGrade 2 AEs3 Participants
Secondary

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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs6 Participants
PF-04950615 (RN316) 4 mg/kg + AtorvastatinNumber of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs0 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)SAEs0 Participants
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinNumber of Participants With Treatment-Related Adverse Events (AEs) and Serious Adverse Events (SAEs)AEs0 Participants
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 155.10 percent changeStandard Deviation 6.31
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 367.30 percent changeStandard Deviation 7.64
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 72.90 percent changeStandard Deviation 7.14
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 435.80 percent changeStandard Deviation 7.73
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 224.40 percent changeStandard Deviation 8.27
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 504.50 percent changeStandard Deviation 5.77
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6-1.00 percent changeStandard Deviation 7.27
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 573.40 percent changeStandard Deviation 8.71
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 295.20 percent changeStandard Deviation 9.94
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 640.80 percent changeStandard Deviation 7.48
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5-1.90 percent changeStandard Deviation 7.48
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6416.90 percent changeStandard Deviation 14.18
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 52.10 percent changeStandard Deviation 6.61
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6-4.20 percent changeStandard Deviation 6.8
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 7-0.80 percent changeStandard Deviation 7.97
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 159.10 percent changeStandard Deviation 12.52
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 2211.50 percent changeStandard Deviation 11.39
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 297.80 percent changeStandard Deviation 17.55
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 368.80 percent changeStandard Deviation 11.09
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 4311.60 percent changeStandard Deviation 12.44
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 503.50 percent changeStandard Deviation 16.45
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein A1 (ApoA1) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5718.80 percent changeStandard Deviation 7.84
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 15-48.60 percent changeStandard Deviation 13.82
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 36-48.80 percent changeStandard Deviation 9.97
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 7-33.80 percent changeStandard Deviation 12.27
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 43-33.80 percent changeStandard Deviation 8.98
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 22-51.50 percent changeStandard Deviation 11.04
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 50-13.70 percent changeStandard Deviation 13.7
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6-26.90 percent changeStandard Deviation 11.01
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 57-5.80 percent changeStandard Deviation 18.03
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 29-53.70 percent changeStandard Deviation 10.37
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 643.00 percent changeStandard Deviation 12.82
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5-13.50 percent changeStandard Deviation 9.25
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6411.50 percent changeStandard Deviation 25.5
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5-17.10 percent changeStandard Deviation 11.22
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6-31.10 percent changeStandard Deviation 13.84
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 7-36.10 percent changeStandard Deviation 15.68
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 15-24.80 percent changeStandard Deviation 18.18
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 22-0.70 percent changeStandard Deviation 19.21
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 293.80 percent changeStandard Deviation 26.31
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 361.50 percent changeStandard Deviation 22.64
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 432.70 percent changeStandard Deviation 18.81
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 50-1.50 percent changeStandard Deviation 21.38
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Apolipoprotein B (ApoB) Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 579.40 percent changeStandard Deviation 19.89
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 1511.10 percent changeStandard Deviation 19.48
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 367.80 percent changeStandard Deviation 11.5
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 7-1.10 percent changeStandard Deviation 9.29
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 4314.50 percent changeStandard Deviation 15.67
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 2213.90 percent changeStandard Deviation 9.65
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 506.10 percent changeStandard Deviation 13.89
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6-3.60 percent changeStandard Deviation 8.24
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 576.10 percent changeStandard Deviation 11.93
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 2914.00 percent changeStandard Deviation 15.04
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 640.50 percent changeStandard Deviation 12.37
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5-2.50 percent changeStandard Deviation 11.27
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 648.20 percent changeStandard Deviation 12.15
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5-1.70 percent changeStandard Deviation 10.93
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6-0.90 percent changeStandard Deviation 18.31
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 7-0.90 percent changeStandard Deviation 18.01
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 1513.40 percent changeStandard Deviation 12.4
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 228.00 percent changeStandard Deviation 11.23
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 293.00 percent changeStandard Deviation 11.72
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 367.50 percent changeStandard Deviation 17.15
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 438.70 percent changeStandard Deviation 8.79
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 506.70 percent changeStandard Deviation 14.2
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting High-Density Lipoprotein (HDL) Cholesterol Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5714.00 percent changeStandard Deviation 19.37
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 15-61.10 percent changeStandard Deviation 31.98
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 36-68.20 percent changeStandard Deviation 15.59
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 7-38.90 percent changeStandard Deviation 24.15
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 43-41.80 percent changeStandard Deviation 18.87
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 22-71.60 percent changeStandard Deviation 21.89
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 50-14.70 percent changeStandard Deviation 17.1
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6-33.80 percent changeStandard Deviation 20.61
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 571.40 percent changeStandard Deviation 24.8
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 29-68.70 percent changeStandard Deviation 22.2
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6413.40 percent changeStandard Deviation 31.22
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5-15.70 percent changeStandard Deviation 23.36
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6425.60 percent changeStandard Deviation 42.94
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5-27.30 percent changeStandard Deviation 23.6
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6-47.00 percent changeStandard Deviation 30.57
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 7-65.10 percent changeStandard Deviation 31.82
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 15-33.30 percent changeStandard Deviation 29.8
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 2211.40 percent changeStandard Deviation 46.23
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 2921.60 percent changeStandard Deviation 46.26
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 3614.90 percent changeStandard Deviation 36.9
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 4319.70 percent changeStandard Deviation 38.86
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5013.70 percent changeStandard Deviation 37.36
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Low Density Lipoprotein-Cholesterol (LDL-C) at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5723.60 percent changeStandard Deviation 47.93
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent 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 64Percent change at Day 15-56.00 percent changeStandard Deviation 26.05
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent 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 64Percent change at Day 36-57.30 percent changeStandard Deviation 16.6
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent 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 64Percent change at Day 7-32.80 percent changeStandard Deviation 18.81
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent 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 64Percent change at Day 43-35.70 percent changeStandard Deviation 16.64
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent 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 64Percent change at Day 22-63.90 percent changeStandard Deviation 18
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent 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 64Percent change at Day 50-9.40 percent changeStandard Deviation 16.55
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent 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 64Percent change at Day 6-28.70 percent changeStandard Deviation 16.69
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent 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 64Percent change at Day 577.80 percent changeStandard Deviation 26.93
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent 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 64Percent change at Day 29-63.90 percent changeStandard Deviation 17.86
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent 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 64Percent change at Day 6415.60 percent changeStandard Deviation 20.3
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent 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 64Percent change at Day 5-9.90 percent changeStandard Deviation 20.47
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent 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 64Percent change at Day 6421.20 percent changeStandard Deviation 35.27
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent 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 64Percent change at Day 5-20.30 percent changeStandard Deviation 15.38
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent 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 64Percent change at Day 6-37.60 percent changeStandard Deviation 26.74
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent 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 64Percent change at Day 7-50.00 percent changeStandard Deviation 26.78
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent 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 64Percent change at Day 15-25.40 percent changeStandard Deviation 26.16
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent 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 64Percent change at Day 2214.70 percent changeStandard Deviation 40.72
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent 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 64Percent change at Day 2916.10 percent changeStandard Deviation 40.69
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent 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 64Percent change at Day 3614.00 percent changeStandard Deviation 36.59
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent 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 64Percent change at Day 4314.30 percent changeStandard Deviation 35.8
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent 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 64Percent change at Day 5012.90 percent changeStandard Deviation 38.29
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent 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 64Percent change at Day 5723.80 percent changeStandard Deviation 44.36
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 15-6.10 percent changeStandard Deviation 41.62
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 36-15.90 percent changeStandard Deviation 32.23
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 75.00 percent changeStandard Deviation 21.2
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 43-7.90 percent changeStandard Deviation 25.94
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 22-2.20 percent changeStandard Deviation 30.73
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5012.60 percent changeStandard Deviation 42.61
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 67.40 percent changeStandard Deviation 20.29
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5720.10 percent changeStandard Deviation 45.52
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 29-14.60 percent changeStandard Deviation 20.02
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6428.60 percent changeStandard Deviation 42.51
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 511.20 percent changeStandard Deviation 65.46
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 647.60 percent changeStandard Deviation 30.24
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5-3.30 percent changeStandard Deviation 24.88
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 61.10 percent changeStandard Deviation 22.05
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 70.50 percent changeStandard Deviation 27.67
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 15-1.40 percent changeStandard Deviation 35.76
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 2219.90 percent changeStandard Deviation 42.17
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 290.80 percent changeStandard Deviation 34.11
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 3612.20 percent changeStandard Deviation 45.69
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 433.20 percent changeStandard Deviation 33.05
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5012.10 percent changeStandard Deviation 49.12
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Fasting Triglycerides Values at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5722.20 percent changeStandard Deviation 41.65
Secondary

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.

ArmMeasureGroupValue (MEAN)Dispersion
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 29-39.40 percent changeStandard Deviation 14.5
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6-21.20 percent changeStandard Deviation 10.16
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 36-36.30 percent changeStandard Deviation 14
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 15-35.40 percent changeStandard Deviation 19.65
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 43-18.90 percent changeStandard Deviation 10.34
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5-8.30 percent changeStandard Deviation 11.81
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 50-3.70 percent changeStandard Deviation 11.17
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 22-38.40 percent changeStandard Deviation 16.7
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 577.50 percent changeStandard Deviation 19.31
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6410.10 percent changeStandard Deviation 14.86
PF-04950615 (RN316) 4 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 7-23.10 percent changeStandard Deviation 14.16
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6412.50 percent changeStandard Deviation 18.07
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5-14.60 percent changeStandard Deviation 8.87
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 6-26.20 percent changeStandard Deviation 10.56
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 7-34.10 percent changeStandard Deviation 11.39
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 15-14.40 percent changeStandard Deviation 18.89
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 227.40 percent changeStandard Deviation 21.95
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 297.40 percent changeStandard Deviation 19.86
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 367.00 percent changeStandard Deviation 21.5
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 439.00 percent changeStandard Deviation 21.22
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 506.00 percent changeStandard Deviation 19.62
PF-04950615 (RN316) 0.5 mg/kg + AtorvastatinPercent Change From Baseline in Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64Percent change at Day 5714.30 percent changeStandard Deviation 20.05

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026