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A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia

Last updated on December 5, 2018

FOR MORE INFORMATION
Study Location
Profil Institute for Clinical Research, Inc.
Chula Vista, California, 91911 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypercholesterolemia, Dyslipidemias, Hyperlipidemias, Lipid Metabolism Disorders, Metabolic Diseases
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01435382
Pfizer
Completed
A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 (RN316) in Subjects With Hypercholesterolemia

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A Pharmacokinetic and Pharmacodynamic Study of PF-04950615 in Subjects With Hypercholesterolemia
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • Hypercholesterolemia
  • Dyslipidemias
  • Hyperlipidemias
  • Lipid Metabolism Disorders
  • Metabolic Diseases
  • Biological: PF-04950615
    Dose A - single-dose intravenous infusion
  • Biological: PF-04950615
    Dose B - single-dose subcutaneous injection
  • Biological: PF-04950615
    Dose C - single-dose subcutaneous injection
  • Biological: PF-04950615
    Dose D - single-dose subcutaneous injection
  • Experimental: Group A
    Intervention: Biological: PF-04950615
  • Experimental: Group B
    Intervention: Biological: PF-04950615
  • Experimental: Group C
    Intervention: Biological: PF-04950615
  • Experimental: Group D
    Intervention: Biological: PF-04950615
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
February 2012
February 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01435382
B1481006
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2012

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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