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Trial record 1 of 1 for:    NCT01720537
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A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects

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ClinicalTrials.gov Identifier: NCT01720537
Recruitment Status : Completed
First Posted : November 2, 2012
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE August 3, 2012
First Posted Date  ICMJE November 2, 2012
Last Update Posted Date December 4, 2018
Study Start Date  ICMJE July 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2013)
  • 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.
  • Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: 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 [ 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2012)
  • Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Day 85 or Early Termination (ET) ]
  • Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: Baseline up to Day 85 or Early Termination (ET) ]
  • Change From Baseline in Heart Rate [ Time Frame: Baseline, Day 1 to 85 or ET ]
  • Diastolic Blood Pressure [ Time Frame: Baseline, Day 1 to 85 or ET ]
  • Change From Baseline in Electrocardiogram (ECG) Parameters [ Time Frame: Baseline, Day 1 to 85 or ET ]
  • Number of Participants With Laboratory Test Values of Potential Clinical Importance [ Time Frame: Baseline, Day 1 to 85 or ET ]
Change History Complete list of historical versions of study NCT01720537 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2013)
  • 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 ]
    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 ]
    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 ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day1 pre-dose to Day 85/169 or ET ]
  • Apparent Volume of Distribution (Vz/F) [ Time Frame: 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.
  • Apparent Oral Clearance (CL/F) [ Time Frame: 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.
  • Plasma Decay Half-Life (t1/2) [ Time Frame: 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.
  • Absolute Bioavailability (%F) [ Time Frame: Day1 pre-dose to Day 85/169 or ET ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2012)
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] [ Time Frame: Day1 pre-dose to Day 85/ET ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)] [ Time Frame: Day1 pre-dose to Day 85/ET ]
  • Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Day1 pre-dose to Day 85/ET ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) [ Time Frame: Day1 pre-dose to Day 85/ET ]
  • Apparent Volume of Distribution (Vz/F) [ Time Frame: Day1 pre-dose to Day 85/ET ]
  • Apparent Oral Clearance (CL/F) [ Time Frame: Day1 pre-dose to Day 85/ET ]
  • Plasma Decay Half-Life (t1/2) [ Time Frame: Day1 pre-dose to Day 85/ET ]
  • Absolute Bioavailability (%F) [ Time Frame: Day1 pre-dose to Day 85/ET ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Hypercholesterolemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2018)
133
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2012)
110
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01720537
Other Study ID Numbers  ICMJE B3091001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2018

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