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

November 30, 2018 updated by: Pfizer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, United States, 33169
        • Pfizer Investigational Site
      • South Miami, Florida, United States, 33143
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Pfizer Investigational Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Pfizer Investigational Site
    • Texas
      • San Antonio, Texas, United States, 78209
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1
Biological: PF-05335810 Dose A
Single SC Injection
Experimental: Cohort 2
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
Experimental: Cohort 3
Biological: Placebo
Single Subcutaneous Injection(s)
Biological: Placebo
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)
Experimental: Cohort 4
Biological: Placebo
Single Subcutaneous Injection(s)
Biological: Placebo
Single Intravenous Infusion
Biological: PF-05335810 Dose D
Single Subcutaneous Injection(s)
Biological: PF-05335810 Dose D
Single Intravenous Infusion
Experimental: Cohort 5
Biological: PF-05335810 Dose E
Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.
Experimental: Cohort 6
Biological: Placebo
Single Subcutaneous Injection(s)
Biological: Placebo
Single Intravenous Infusion
Biological: PF-05335810 Dose D
Single Subcutaneous Injection(s)
Biological: PF-05335810 Dose D
Single Intravenous Infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline up to Day 85/169 or Early Termination (ET)
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.
Baseline up to Day 85/169 or Early Termination (ET)
Change From Baseline in Heart Rate
Time Frame: Baseline, Day 1 to 85/169 or ET
Baseline, Day 1 to 85/169 or ET
Diastolic Blood Pressure
Time Frame: Baseline, Day 1 to 85/169 or ET
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
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.
Baseline, Day 1 to 85/169 or ET

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Day1 pre-dose to Day 85/169 or ET
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)
Day1 pre-dose to Day 85/169 or ET
Maximum Observed Plasma Concentration (Cmax)
Time Frame: Day1 pre-dose to Day 85/169 or ET
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
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.
Day1 pre-dose to Day 85/169 or ET
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.
Day1 pre-dose to Day 85/169 or ET
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.
Day1 pre-dose to Day 85/169 or ET
Absolute Bioavailability (%F)
Time Frame: Day1 pre-dose to Day 85/169 or ET
Day1 pre-dose to Day 85/169 or ET

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

August 3, 2012

First Submitted That Met QC Criteria

October 31, 2012

First Posted (Estimate)

November 2, 2012

Study Record Updates

Last Update Posted (Actual)

December 4, 2018

Last Update Submitted That Met QC Criteria

November 30, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B3091001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypercholesterolemia

Clinical Trials on PF-05335810 Dose A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in South Africa

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe