Skip to main content
OpenTrials
Completed

NCT Number: NCT01720537

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%).

Treatment and study plan

PF-05335810 Dose A

Biological

Single SC Injection

PF-05335810 Dose B

Biological

Single Subcutaneous Injection(s)

Placebo

Biological

Single Subcutaneous Injection(s)

PF-04950615 Dose A

Biological

Single Subcutaneous Injection(s)

PF-05335810 Dose C

Biological

Single Subcutaneous Injection(s)

PF-04950615

Biological

Single Subcutaneous Injection(s)

PF-05335810 Dose D

Biological

Single Subcutaneous Injection(s)

PF-05335810 Dose E

Biological

Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.

Primary outcomes

  1. 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.

  2. 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.

  3. Change From Baseline in Heart Rate

    Time frame: Baseline, Day 1 to 85/169 or ET

  4. Diastolic Blood Pressure

    Time frame: Baseline, Day 1 to 85/169 or ET

  5. Change From Baseline in Electrocardiogram (ECG) Parameters

    Time frame: Baseline, Day 1 to 85/169 or ET

  6. 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.

Secondary outcomes

  1. 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).

  2. 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)

  3. Maximum Observed Plasma Concentration (Cmax)

    Time frame: Day1 pre-dose to Day 85/169 or ET

  4. Time to Reach Maximum Observed Plasma Concentration (Tmax)

    Time frame: Day1 pre-dose to Day 85/169 or ET

  5. 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.

  6. 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.

  7. 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.

  8. Absolute Bioavailability (%F)

    Time frame: Day1 pre-dose to Day 85/169 or ET

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 2, 2012
Registry last updated
Dec 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.