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

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-05335810 Dose A
PF-05335810 Dose B
Placebo
PF-05335810 Dose B
Placebo
PF-04950615 Dose A
PF-04950615 Dose A
PF-05335810 Dose C
Placebo
PF-05335810 Dose C
Placebo
PF-04950615
PF-05335810 Dose D
Placebo
PF-05335810 Dose E
PF-05335810 Dose D
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypercholesterolemia focused on measuring High Cholesterol, Dyslipidemia

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%).

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
Change From Baseline in Heart Rate
Diastolic Blood Pressure
Change From Baseline in Electrocardiogram (ECG) Parameters
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.

Secondary Outcome Measures

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
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)]
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 to Reach Maximum Observed Plasma Concentration (Tmax)
Apparent Volume of Distribution (Vz/F)
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)
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)
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Absolute Bioavailability (%F)

Full Information

First Posted
August 3, 2012
Last Updated
November 30, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01720537
Brief Title
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

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
High Cholesterol, Dyslipidemia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
133 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Title
Cohort 2
Arm Type
Experimental
Arm Title
Cohort 3
Arm Type
Experimental
Arm Title
Cohort 4
Arm Type
Experimental
Arm Title
Cohort 5
Arm Type
Experimental
Arm Title
Cohort 6
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
PF-05335810 Dose A
Intervention Description
Single SC Injection
Intervention Type
Biological
Intervention Name(s)
PF-05335810 Dose B
Intervention Description
Single Subcutaneous Injection(s)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Single Subcutaneous Injection(s)
Intervention Type
Biological
Intervention Name(s)
PF-05335810 Dose B
Intervention Description
Single Intravenous Infusion
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Single Intravenous Infusion
Intervention Type
Biological
Intervention Name(s)
PF-04950615 Dose A
Intervention Description
Single Subcutaneous Injection(s)
Intervention Type
Biological
Intervention Name(s)
PF-04950615 Dose A
Intervention Description
Single Intravenous Infusion
Intervention Type
Biological
Intervention Name(s)
PF-05335810 Dose C
Intervention Description
Single Subcutaneous Injection(s)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Single Subcutaneous Injection(s)
Intervention Type
Biological
Intervention Name(s)
PF-05335810 Dose C
Intervention Description
Single Intravenous Infusion
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Single Intravenous Infusion
Intervention Type
Biological
Intervention Name(s)
PF-04950615
Intervention Description
Single Subcutaneous Injection(s)
Intervention Type
Biological
Intervention Name(s)
PF-05335810 Dose D
Intervention Description
Single Subcutaneous Injection(s)
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Single Subcutaneous Injection(s)
Intervention Type
Biological
Intervention Name(s)
PF-05335810 Dose E
Intervention Description
Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.
Intervention Type
Biological
Intervention Name(s)
PF-05335810 Dose D
Intervention Description
Single Intravenous Infusion
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Single Intravenous Infusion
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline up to Day 85/169 or Early Termination (ET)
Title
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Description
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
Time Frame
Baseline up to Day 85/169 or Early Termination (ET)
Title
Change From Baseline in Heart Rate
Time Frame
Baseline, Day 1 to 85/169 or ET
Title
Diastolic Blood Pressure
Time Frame
Baseline, Day 1 to 85/169 or ET
Title
Change From Baseline in Electrocardiogram (ECG) Parameters
Time Frame
Baseline, Day 1 to 85/169 or ET
Title
Number of Participants With Laboratory Test Values of Potential Clinical Importance
Description
Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
Time Frame
Baseline, Day 1 to 85/169 or ET
Secondary Outcome Measure Information:
Title
Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
Description
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).
Time Frame
Day1 pre-dose to Day 85/169 or ET
Title
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
Description
AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
Time Frame
Day1 pre-dose to Day 85/169 or ET
Title
Maximum Observed Plasma Concentration (Cmax)
Time Frame
Day1 pre-dose to Day 85/169 or ET
Title
Time to Reach Maximum Observed Plasma Concentration (Tmax)
Time Frame
Day1 pre-dose to Day 85/169 or ET
Title
Apparent Volume of Distribution (Vz/F)
Description
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.
Time Frame
Day1 pre-dose to Day 85/169 or ET
Title
Apparent Oral Clearance (CL/F)
Description
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.
Time Frame
Day1 pre-dose to Day 85/169 or ET
Title
Plasma Decay Half-Life (t1/2)
Description
Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
Day1 pre-dose to Day 85/169 or ET
Title
Absolute Bioavailability (%F)
Time Frame
Day1 pre-dose to Day 85/169 or ET

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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%).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Pfizer Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
Pfizer Investigational Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Pfizer Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B3091001&StudyName=A%20Study%20To%20Assess%20The%20Safety%20Of%20PF-05335810%20In%20Hypercholesterolemic%20Subjects
Description
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A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects

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