A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 in Subjects With Hypercholesterolemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01435382
First received: September 7, 2011
Last updated: March 29, 2012
Last verified: March 2012
  Purpose

This Phase 1 study has been designed to evaluate the absolute bioavailability of PF-04950615 in subjects with hypercholesterolemia who are not currently on lipid-lowering therapy.


Condition Intervention Phase
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Biological: PF-04950615
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1, Open-Label, Randomized, Single Dose, Parallel Group Study to Assess The Pharmacokinetics and Pharmacodynamics of PF-04950615 Following Subcutaneous and Intravenous Doses in Adult Subjects With Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Maximum observed plasma concentration (Cmax) of PF-04950615 [ Time Frame: Days 1, 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85 ] [ Designated as safety issue: No ]
  • Time to reach maximum observed plasma concentration (Tmax) of PF-04950615 [ Time Frame: Days 1, 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) of PF-04950615 [ Time Frame: Days 1, 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve extrapolated to infinity (AUCinf) of PF-04950615 [ Time Frame: Days 1, 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85 ] [ Designated as safety issue: No ]
  • Clearance (CL/F or CL) of PF-04950615 [ Time Frame: Days 1, 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85 ] [ Designated as safety issue: No ]
  • Volume of distribution (Vz/F or Vss) of PF-04950615 [ Time Frame: Days 1, 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85 ] [ Designated as safety issue: No ]
  • Terminal elimination half-life (t1/2) of PF-04950615 [ Time Frame: Days 1, 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85 ] [ Designated as safety issue: No ]
  • Absolute bioavailability (%F)of PF-04950615 [ Time Frame: Days 1, 2, 3, 4, 5, 6, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, 85 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Absolute values of fasting LDL-C after PF-04950615 administration [ Time Frame: Up to 85 days ] [ Designated as safety issue: No ]
  • Percent change from baseline of fasting LDL-C after PF-04950615 administration [ Time Frame: Up to 85 days ] [ Designated as safety issue: No ]
  • Duration of LDL-C lowering effects of PF-04950615 [ Time Frame: Up to 85 days ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: October 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: PF-04950615
Dose A - single-dose intravenous infusion
Experimental: Group B Biological: PF-04950615
Dose B - single-dose subcutaneous injection
Experimental: Group C Biological: PF-04950615
Dose C - single-dose subcutaneous injection
Experimental: Group D Biological: PF-04950615
Dose D - single-dose subcutaneous injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fasting LDL-C greater than or equal to 130 mg/dL at two qualifying screening visits.
  • Total body weight greater than or equal to 50 kg (110 lbs) and less than or equal to 150 kg (330 lbs)

Exclusion Criteria:

  • Lipid-lowering prescription medications, homeopaths, herbal medicines, or nutritional supplements.
  • Poorly controlled type 1 or type 2 diabetes.
  • History of a cardiovascular or cerebrovascular event or related procedure during the past year.
  • Poorly controlled hypertension.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01435382

Locations
United States, California
Pfizer Investigational Site
Chula Vista, California, United States, 91911
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21225
United States, Michigan
Pfizer Investigational Site
Kalamazoo, Michigan, United States, 49007
United States, Minnesota
Pfizer Investigational Site
Saint Paul, Minnesota, United States, 55114
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45212
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01435382     History of Changes
Other Study ID Numbers: B1481006
Study First Received: September 7, 2011
Last Updated: March 29, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Metabolic Diseases
Lipid Metabolism Disorders
Sphingolipidoses
Dyslipidemias
Lysosomal Storage Diseases, Nervous System
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Lipidoses
Lipid Metabolism, Inborn Errors
Lysosomal Storage Diseases

ClinicalTrials.gov processed this record on April 22, 2014