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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
133

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 2, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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