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This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or multiple fixed subcutaneous and intravenous administrations of PF 05335810 to hypercholesterolemic subjects when added on to a daily statin dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
| |
| Cohort 2 | Experimental |
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| Cohort 3 | Experimental |
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| Cohort 4 | Experimental |
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| Cohort 5 | Experimental |
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| Cohort 6 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05335810 Dose A | Biological | Single SC Injection |
| |
| PF-05335810 Dose B |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose. Relatedness to [study drug] was assessed by the investigator (Yes/No). Participants with multiple occurrences of an AE within a category were counted once within the category. | Baseline up to Day 85/169 or Early Termination (ET) |
| Number of Participants With Laboratory Test Values of Potential Clinical Importance | Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. | Baseline up to Day 85/169 or Early Termination (ET) |
| Change From Baseline in Heart Rate | Baseline, Day 1 to 85/169 or ET | |
| Diastolic Blood Pressure | Baseline, Day 1 to 85/169 or ET | |
| Change From Baseline in Electrocardiogram (ECG) Parameters | Baseline, Day 1 to 85/169 or ET | |
| Number of Participants With Laboratory Test Values of Potential Clinical Importance | Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. | Baseline, Day 1 to 85/169 or ET |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8). | Day1 pre-dose to Day 85/169 or ET |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] |
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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 |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Biological |
Single Subcutaneous Injection(s) |
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| Placebo | Biological | Single Subcutaneous Injection(s) |
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| PF-05335810 Dose B | Biological | Single Intravenous Infusion |
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| Placebo | Biological | Single Intravenous Infusion |
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| PF-04950615 Dose A | Biological | Single Subcutaneous Injection(s) |
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| PF-04950615 Dose A | Biological | Single Intravenous Infusion |
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| PF-05335810 Dose C | Biological | Single Subcutaneous Injection(s) |
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| Placebo | Biological | Single Subcutaneous Injection(s) |
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| PF-05335810 Dose C | Biological | Single Intravenous Infusion |
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| Placebo | Biological | Single Intravenous Infusion |
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| PF-04950615 | Biological | Single Subcutaneous Injection(s) |
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| PF-05335810 Dose D | Biological | Single Subcutaneous Injection(s) |
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| Placebo | Biological | Single Subcutaneous Injection(s) |
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| PF-05335810 Dose E | Biological | Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months. |
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| PF-05335810 Dose D | Biological | Single Intravenous Infusion |
|
| Placebo | Biological | Single Intravenous Infusion |
|
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) |
| Day1 pre-dose to Day 85/169 or ET |
| Maximum Observed Plasma Concentration (Cmax) | Day1 pre-dose to Day 85/169 or ET |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Day1 pre-dose to Day 85/169 or ET |
| Apparent Volume of Distribution (Vz/F) | 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. | Day1 pre-dose to Day 85/169 or ET |
| Apparent Oral Clearance (CL/F) | 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. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | Day1 pre-dose to Day 85/169 or ET |
| Plasma Decay Half-Life (t1/2) | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | Day1 pre-dose to Day 85/169 or ET |
| Absolute Bioavailability (%F) | Day1 pre-dose to Day 85/169 or ET |
| Miami |
| Florida |
| 33169 |
| United States |
| Pfizer Investigational Site | South Miami | Florida | 33143 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66212 | United States |
| Pfizer Investigational Site | Kalamazoo | Michigan | 49007 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45227 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78209 | United States |
| 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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