A Phase I, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Ascending Doses Of PF-05335810 In Hypercholesterolemic Subjects, With One, Open-Label, Multiple Fixed Dosage Cohort
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hypercholesterolemia
- Sponsor
- Pfizer
- Enrollment
- 133
- Locations
- 1
- Primary Endpoint
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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%).
Outcomes
Primary Outcomes
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 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.
Change From Baseline in Heart Rate
Time Frame: Baseline, Day 1 to 85/169 or ET
Diastolic Blood Pressure
Time Frame: Baseline, Day 1 to 85/169 or ET
Change From Baseline in Electrocardiogram (ECG) Parameters
Time Frame: Baseline, Day 1 to 85/169 or ET
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Time Frame: Baseline, Day 1 to 85/169 or ET
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
Secondary Outcomes
- Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)](Day1 pre-dose to Day 85/169 or ET)
- Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (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)
- Apparent Oral Clearance (CL/F)(Day1 pre-dose to Day 85/169 or ET)
- Absolute Bioavailability (%F)(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)
- Plasma Decay Half-Life (t1/2)(Day1 pre-dose to Day 85/169 or ET)
- Apparent Volume of Distribution (Vz/F)(Day1 pre-dose to Day 85/169 or ET)