A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01720537
First received: August 3, 2012
Last updated: November 19, 2013
Last verified: November 2013

August 3, 2012
November 19, 2013
July 2012
October 2013   (final data collection date for primary outcome measure)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 85/169 or Early Termination (ET) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline up to Day 85/169 or Early Termination (ET) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline, Day 1 to 85/169 or ET ] [ Designated as safety issue: Yes ]
  • Diastolic Blood Pressure [ Time Frame: Baseline, Day 1 to 85/169 or ET ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Electrocardiogram (ECG) Parameters [ Time Frame: Baseline, Day 1 to 85/169 or ET ] [ Designated as safety issue: Yes ]
  • Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: Baseline, Day 1 to 85/169 or ET ] [ Designated as safety issue: Yes ]
    Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 85 or Early Termination (ET) ] [ Designated as safety issue: Yes ]
  • Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: Baseline up to Day 85 or Early Termination (ET) ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Heart Rate [ Time Frame: Baseline, Day 1 to 85 or ET ] [ Designated as safety issue: Yes ]
  • Diastolic Blood Pressure [ Time Frame: Baseline, Day 1 to 85 or ET ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Electrocardiogram (ECG) Parameters [ Time Frame: Baseline, Day 1 to 85 or ET ] [ Designated as safety issue: Yes ]
  • Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: Baseline, Day 1 to 85 or ET ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01720537 on ClinicalTrials.gov Archive Site
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: Day1 pre-dose to Day 85/169 or ET ] [ Designated as safety issue: No ]
    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).
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: Day1 pre-dose to Day 85/169 or ET ] [ Designated as safety issue: No ]
    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) [ Time Frame: Day1 pre-dose to Day 85/169 or ET ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day1 pre-dose to Day 85/169 or ET ] [ Designated as safety issue: No ]
  • Apparent Volume of Distribution (Vz/F) [ Time Frame: Day1 pre-dose to Day 85/169 or ET ] [ Designated as safety issue: No ]
    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.
  • Apparent Oral Clearance (CL/F) [ Time Frame: Day1 pre-dose to Day 85/169 or ET ] [ Designated as safety issue: No ]
    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.
  • Plasma Decay Half-Life (t1/2) [ Time Frame: Day1 pre-dose to Day 85/169 or ET ] [ Designated as safety issue: No ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
  • Absolute Bioavailability (%F) [ Time Frame: Day1 pre-dose to Day 85/169 or ET ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: Day1 pre-dose to Day 85/ET ] [ Designated as safety issue: No ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: Day1 pre-dose to Day 85/ET ] [ Designated as safety issue: No ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day1 pre-dose to Day 85/ET ] [ Designated as safety issue: No ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day1 pre-dose to Day 85/ET ] [ Designated as safety issue: No ]
  • Apparent Volume of Distribution (Vz/F) [ Time Frame: Day1 pre-dose to Day 85/ET ] [ Designated as safety issue: No ]
  • Apparent Oral Clearance (CL/F) [ Time Frame: Day1 pre-dose to Day 85/ET ] [ Designated as safety issue: No ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: Day1 pre-dose to Day 85/ET ] [ Designated as safety issue: No ]
  • Absolute Bioavailability (%F) [ Time Frame: Day1 pre-dose to Day 85/ET ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Hypercholesterolemia
  • Biological: PF-05335810 Dose A
    Single SC Injection
  • Biological: PF-05335810 Dose B
    Single Subcutaneous Injection(s)
  • Biological: Placebo
    Single Subcutaneous Injection(s)
  • Biological: PF-05335810 Dose B
    Single Intravenous Infusion
  • Biological: Placebo
    Single Intravenous Infusion
  • Biological: PF-04950615 Dose A
    Single Subcutaneous Injection(s)
  • Biological: PF-04950615 Dose A
    Single Intravenous Infusion
  • Biological: PF-05335810 Dose C
    Single Subcutaneous Injection(s)
  • Biological: PF-05335810 Dose C
    Single Intravenous Infusion
  • Biological: PF-04950615
    Single Subcutaneous Injection(s)
  • Biological: PF-05335810 Dose D
    Single Subcutaneous Injection(s)
  • Biological: PF-05335810 Dose E
    Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.
  • Biological: PF-05335810 Dose D
    Single Intravenous Infusion
  • Experimental: Cohort 1
    Intervention: Biological: PF-05335810 Dose A
  • Experimental: Cohort 2
    Interventions:
    • Biological: PF-05335810 Dose B
    • Biological: Placebo
    • Biological: PF-05335810 Dose B
    • Biological: Placebo
    • Biological: PF-04950615 Dose A
    • Biological: PF-04950615 Dose A
  • Experimental: Cohort 3
    Interventions:
    • Biological: PF-05335810 Dose C
    • Biological: Placebo
    • Biological: PF-05335810 Dose C
    • Biological: Placebo
    • Biological: PF-04950615
  • Experimental: Cohort 4
    Interventions:
    • Biological: PF-05335810 Dose D
    • Biological: Placebo
  • Experimental: Cohort 5
    Intervention: Biological: PF-05335810 Dose E
  • Experimental: Cohort 6
    Interventions:
    • Biological: PF-05335810 Dose D
    • Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
136
October 2013
October 2013   (final data collection date for primary outcome measure)

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%).
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01720537
B3091001
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP