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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-04950615 (RN316) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 4 mg/kg | Biological | RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615 | 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | |
| Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 | |
| Plasma Decay Half-Life (t1/2) of PF-04950615 | Plasma decay half-life is the time measured for the plasma concentration of PF-04950615 to decrease by one half. | 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 |
| Systemic Clearance (CL) of PF-04950615 | CL is a quantitative measure of the rate at which a drug substance is removed from the body. | 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 |
| Volume of Distribution 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
| Change From Baseline in Fasting Total Cholesterol at Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Research Group, Limited | Peoria | Arizona | 85381 | United States | ||
| Dedicated Phase 1, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37994400 | Derived | Wang EQ, Kaila N, Plowchalk D, Gibiansky L, Yunis C, Sweeney K. Population PK/PD modeling of low-density lipoprotein cholesterol response in hypercholesterolemic participants following administration of bococizumab, a potent anti-PCSK9 monoclonal antibody. CPT Pharmacometrics Syst Pharmacol. 2023 Dec;12(12):2013-2026. doi: 10.1002/psp4.13050. Epub 2023 Nov 22. | |
| 28181260 |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Full analysis set included all participants who met the study enrollment criteria and received any amount of study medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-04950615 | Pharmacokinetic (PK) parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Standard Deviation | nanogram*hour per milliliter | 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 |
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
All determinations of primary or secondary outcomes were arbitrary as study did not specify primary or secondary outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
Not provided
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000598888 | bococizumab |
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| 0.5 mg/kg | Biological | RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes. |
|
|
| 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of PF-04950615 | 0 (pre-dose on Day 4), 1, 4, 8 and 12 hours (hrs) post intravenous PF-04950615 (RN316) dose, pre atorvastatin dose on Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57 and 64 |
| Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of Atorvastatin | AUCtau was the AUC from time 0 to the end of the dosing interval, where the dosing interval was 12 hours. | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4 |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7 |
| Maximum Observed Plasma Concentration (Cmax) of Atorvastatin | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4, pre atorvastatin dose on Day 5, 6 and 7 |
| Plasma Decay Half-Life (t1/2) of Atorvastatin | Plasma decay half-life is the time measured for the plasma concentration of atorvastatin to decrease by one half. | 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 |
| 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. | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4 |
| 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. | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4 |
Baseline value calculated as average of Day 2 and Day 4 measurements prior to PF-04950615 administration. |
| Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
| 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. | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
| 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. | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
| 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. | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
| 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. | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
| 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. | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
| 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. | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
| 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. | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
| 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. | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
| 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. | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
| 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. | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
| 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. | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
| 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. | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
| 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. | Day 4 to Day 64 |
| 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. | Day 1 up to Day 64 |
| 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. | Day 1 up to Day 64 |
| 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 | Day 1 up to Day 64 |
| 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. | Day 1 up to Day 64 |
| 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. | Day 1 up to Day 64 |
| 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 | Day 1 up to Day 64 |
| 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. | Day 1 up to Day 64 |
| 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. | Day 1 up to Day 64 |
| 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. | Day 1 up to Day 64 |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| Premier Research Group Limited | Phoenix | Arizona | 85027 | United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66211 | United States |
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
| Udata C, Garzone PD, Gumbiner B, Joh T, Liang H, Liao KH, Williams JH, Meng X. A Mechanism-Based Pharmacokinetic/Pharmacodynamic Model for Bococizumab, a Humanized Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9, and Its Application in Early Clinical Development. J Clin Pharmacol. 2017 Jul;57(7):855-864. doi: 10.1002/jcph.867. Epub 2017 Feb 9. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-04950615 | PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. | Posted | Median | Full Range | hour | 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 |
|
|
|
| Primary | Maximum Observed Plasma Concentration (Cmax) of PF-04950615 | PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Standard Deviation | nanogram per milliliter | 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 |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | hour | 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 |
|
|
|
| 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. | 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. | Posted | Geometric Mean | Standard Deviation | liter per hour | 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 |
|
|
|
| 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. | 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. | Posted | Geometric Mean | Standard Deviation | liter | 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 |
|
|
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| Primary | Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) of PF-04950615 | 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. | Posted | Geometric Mean | Standard Deviation | nanogram*hour per milliliter | 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 |
|
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| 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. | PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Standard Deviation | nanogram*hour per milliliter | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4 |
|
|
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| Primary | Time to Reach Maximum Observed Plasma Concentration (Tmax) of Atorvastatin | PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. | Posted | Median | Full Range | hour | 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 |
|
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| Primary | Maximum Observed Plasma Concentration (Cmax) of Atorvastatin | PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Standard Deviation | nanogram per milliliter | 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 |
|
|
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| 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. | 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. | Posted | Mean | Standard Deviation | hour | 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 |
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| 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. | PK parameter analysis population included all enrolled participants who were treated and had at least 1 of the PK parameters of interest. | Posted | Geometric Mean | Standard Deviation | liter per hour | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4 |
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| 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. | 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. | Posted | Geometric Mean | Standard Deviation | liter | 0 (pre-dose), 0.25, 0.5, 1, 2, 3, 4, 6, 8 and 12 hrs post-dose on Day 4 |
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| 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. | 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. | Posted | Mean | Standard Deviation | milligram per deciliter | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
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| 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. | 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. | Posted | Mean | Standard Deviation | milligram per deciliter | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
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| 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. | 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. | Posted | Mean | Standard Deviation | milligram per deciliter | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
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| 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. | 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. | Posted | Mean | Standard Deviation | milligram per deciliter | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
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| 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. | 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. | Posted | Mean | Standard Deviation | milligram per deciliter | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
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| 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. | 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. | Posted | Mean | Standard Deviation | milligram per deciliter | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
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| 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. | 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. | Posted | Mean | Standard Deviation | milligram per deciliter | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
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| 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. | 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. | Posted | Mean | Standard Deviation | percent change | Baseline, Day 5, 6, 7, 15, 22, 29, 36, 43, 50, 57, 64 |
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| 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. | Pharmacodynamic analysis population included all enrolled participants who received any amount of study medication and had at least 1 pharmacodynamic parameter of interest. | Posted | Median | Full Range | days | Day 4 to Day 64 |
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| 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. | Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication. | Posted | Count of Participants | Participants | Day 1 up to Day 64 |
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| 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. | Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication. | Posted | Count of Participants | Participants | Day 1 up to Day 64 |
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| 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 | Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication. | Posted | Count of Participants | Participants | Day 1 up to Day 64 |
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| 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. | Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication. | Posted | Count of Participants | Participants | Day 1 up to Day 64 |
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| 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. | Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication. | Posted | Count of Participants | Participants | Day 1 up to Day 64 |
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| 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 | Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication. | Posted | Count of Participants | Participants | Day 1 up to Day 64 |
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| 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. | Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication. | Posted | Count of Participants | Participants | Day 1 up to Day 64 |
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| 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. | Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication. | Posted | Count of Participants | Participants | Day 1 up to Day 64 |
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| 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. | Safety analysis population included all participants who met the study enrollment criteria and had received any amount of study medication. | Posted | Count of Participants | Participants | Day 1 up to Day 64 |
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| 1 |
| 12 |
| 12 |
| 12 |
| EG001 | 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. | 0 | 12 | 11 | 12 |
| Ear pain | Ear and labyrinth disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Conjunctivitis | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Anorectal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Chills | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Hordeolum | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Oral herpes | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
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| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
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| Alanine aminotransferase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
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| Aspartate aminotransferase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
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| Blood amylase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
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| Blood lactate dehydrogenase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
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| Blood pressure increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
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| Heart rate increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
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| Lipase increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Sinus headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Pelvic pain | Reproductive system and breast disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Hot flush | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
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| Phlebitis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
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| Percent change at Day 57 |
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|
| Percent change at Day 64 |
|
|
| Grade 3 AEs |
|
| Unknown |
|
| Grade 1 AEs: (All causalities) |
|
| Grade 2 AEs: (All causalities) |
|
| Grade 1 AEs: (All causalities) |
|
| Grade 1 AEs: (All causalities) |
|
| Grade 1 AEs: (Treatment related) |
|
| Grade 2 AEs: (Treatment related) |
|
| Grade 3 AEs: (Treatment related) |
|