Clinical trial NCT01720537: A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypercholesterolemia
Keywords: High Cholesterol
Dyslipidemia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-11-02
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


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%).

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Day 85/169 or Early Termination (ET)
measure: Number of Participants With Laboratory Test Values of Potential Clinical Importance
timeFrame: Baseline up to Day 85/169 or Early Termination (ET)
measure: Change From Baseline in Heart Rate
timeFrame: Baseline, Day 1 to 85/169 or ET
measure: Diastolic Blood Pressure
timeFrame: Baseline, Day 1 to 85/169 or ET
measure: Change From Baseline in Electrocardiogram (ECG) Parameters
timeFrame: Baseline, Day 1 to 85/169 or ET
measure: Number of Participants With Laboratory Test Values of Potential Clinical Importance
timeFrame: Baseline, Day 1 to 85/169 or ET
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: Day1 pre-dose to Day 85/169 or ET
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
timeFrame: Day1 pre-dose to Day 85/169 or ET
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Day1 pre-dose to Day 85/169 or ET
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Day1 pre-dose to Day 85/169 or ET
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: Day1 pre-dose to Day 85/169 or ET
measure: Apparent Oral Clearance (CL/F)
timeFrame: Day1 pre-dose to Day 85/169 or ET
measure: Plasma Decay Half-Life (t1/2)
timeFrame: Day1 pre-dose to Day 85/169 or ET
measure: Absolute Bioavailability (%F)
timeFrame: Day1 pre-dose to Day 85/169 or ET
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: