Safety And Tolerability Of Multiple Doses Of PF-04950615 (RN316) In Subjects With Hypercholesterolemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01243151
First received: November 3, 2010
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

The primary objective of this study is to evaluate the safety and tolerability of repeated doses of PF-04950615 (RN316) in study volunteers with hypercholesterolemia. PF-04950615 is an investigational drug that is currently being studied as a lipid lowering agent.


Condition Intervention Phase
Hypercholesterolemia
Dyslipidemia
Biological: PF-04950615 (RN316)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Multiple Intravenous Doses Of PF-04950615 (RN316) In Healthy Adult Subjects With Hypercholesterolemia

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Incidence of dose limiting or intolerable treatment related adverse events (AEs). [ Time Frame: 14 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence, severity and causal relationship of treatment emergent Adverse Eventss (TEAEs). [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence of abnormal and clinically relevant safety laboratories. [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters. [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]
  • Incidence of anti-drug-antibodies. [ Time Frame: 14 Weeks ] [ Designated as safety issue: Yes ]

Enrollment: 68
Study Start Date: February 2011
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A Biological: PF-04950615 (RN316)
Infusion every week
Other Name: PF-04950615 (RN316)
Experimental: B Biological: PF-04950615 (RN316)
Infusion every week
Other Name: PF-04950615 (RN316)
Experimental: C Biological: PF-04950615 (RN316)
Infusion every week
Other Name: PF-04950615 (RN316)
Experimental: D Biological: PF-04950615 (RN316)
Infusion every week
Other Name: PF-04950615 (RN316)
Experimental: E Biological: PF-04950615 (RN316)
Infusion every week
Other Name: PF-04950615 (RN316)

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LDL-C must be greater or equal to 130 mg/dl
  • BMI must be between 18.5 and 40 kg/m2
  • Japanese volunteers must have 4 Japanese grand parents born in Japan

Exclusion Criteria:

  • History of cardiovascular or cerebrovascular event during the past year.
  • Poorly controlled type 1 or type 2 diabetes mellitus
  • Subjects who have taken lipid lowering therapies within the last 3 months of screening.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01243151

Locations
United States, California
Pfizer Investigational Site
Culver City, California, United States, 90232
Pfizer Investigational Site
Glendale, California, United States, 91206
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33126
Pfizer Investigational Site
Miami, Florida, United States, 33134
United States, Hawaii
Pfizer Investigational Site
Honolulu, Hawaii, United States, 96813
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
United States, Minnesota
Pfizer Investigational Site
Saint Paul, Minnesota, United States, 55114
United States, Texas
Pfizer Investigational Site
San Antonio, Texas, United States, 78209
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: NCT01243151     History of Changes
Other Study ID Numbers: B1481009
Study First Received: November 3, 2010
Last Updated: July 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Hypercholesterolemia
Dyslipidemia
LDL
High Cholesterol
Japanese Volunteers
PF-04950615
RN316

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 01, 2014