A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects
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
1 other identifier
interventional
133
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2012
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
August 3, 2012
CompletedFirst Posted
Study publicly available on registry
November 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedDecember 4, 2018
November 1, 2018
1.3 years
August 3, 2012
November 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Secondary Outcomes (8)
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
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
- +3 more secondary outcomes
Study Arms (6)
Cohort 1
EXPERIMENTALCohort 2
EXPERIMENTALCohort 3
EXPERIMENTALCohort 4
EXPERIMENTALCohort 5
EXPERIMENTALCohort 6
EXPERIMENTALInterventions
Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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%).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (7)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Pfizer Investigational Site
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2012
First Posted
November 2, 2012
Study Start
July 1, 2012
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
December 4, 2018
Record last verified: 2018-11