Hypercholesterolemia
Conditions
Keywords
High Cholesterol, Dyslipidemia
Brief summary
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.
Interventions
BIOLOGICALPF-05335810 Dose A
Single SC Injection
BIOLOGICALPF-05335810 Dose B
Single Subcutaneous Injection(s)
BIOLOGICALPlacebo
Single Subcutaneous Injection(s)
BIOLOGICALPF-04950615 Dose A
Single Subcutaneous Injection(s)
BIOLOGICALPF-05335810 Dose C
Single Subcutaneous Injection(s)
BIOLOGICALPF-04950615
Single Subcutaneous Injection(s)
BIOLOGICALPF-05335810 Dose D
Single Subcutaneous Injection(s)
BIOLOGICALPF-05335810 Dose E
Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* On stable daily doses of a statin for 45 days prior to receiving study treatment. * Fasting LDL C equal or greater than 80 mg/dL at screening and visit approximately 1 week prior to randomization.
Exclusion criteria
* History of a cardiovascular or cerebrovascular event or procedure within one year of randomization. * Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c \>9%).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to Day 85/169 or Early Termination (ET) | 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. |
| Number of Participants With Laboratory Test Values of Potential Clinical Importance | Baseline up to Day 85/169 or Early Termination (ET) | Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance. |
| 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 | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Oral Clearance (CL/F) | Day1 pre-dose to Day 85/169 or ET | 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. |
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] | Day1 pre-dose to Day 85/169 or ET | 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). |
| Absolute Bioavailability (%F) | Day1 pre-dose to Day 85/169 or ET | — |
| Plasma Decay Half-Life (t1/2) | Day1 pre-dose to Day 85/169 or ET | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] | Day1 pre-dose to Day 85/169 or ET | AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t) |
| 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) | Day1 pre-dose to Day 85/169 or ET | 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. |
Countries
United States
Outcome results
None listed