Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of RN316 In Combination With Atorvastatin

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01163851
First received: July 14, 2010
Last updated: June 17, 2011
Last verified: June 2011
  Purpose

The primary objective of this study is to evaluate the pharmacokinetics and pharmacodynamics of a single dose of RN316 in volunteers on stable doses of atorvastatin. RN316 is an investigational drug that is currently being studies as a cholesterol lowering therapy.


Condition Intervention Phase
Hypercholesterolemia
Dyslipidemia
Biological: 4 mg/kg
Biological: 0.5 mg/kg
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Study Evaluating The Pharmacokinetics And Pharmacodynamics Of RN316 In Combination With Atorvastatin In Hypercholesterolemic Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Pharmacokinetics parameter estimates of RN316 in the presence of atorvastatin and of atorvastatin after a single IV dose of RN316. [ Time Frame: 2 Months ] [ Designated as safety issue: No ]
  • Absolute and percent change from baseline of fasting LDL-C after RN316 administration [ Time Frame: 2 Months ] [ Designated as safety issue: No ]
  • Incidence of subjects meeting toxicity or intolerable dose criteria [ Time Frame: 2 Months ] [ Designated as safety issue: Yes ]
  • Incidence of treatment emergent adverse events (TEAEs) categorized by severity and causal relationship to study drug. [ Time Frame: 2 Months ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: July 2010
Study Completion Date: April 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RN-316 Biological: 4 mg/kg
RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.
Biological: 0.5 mg/kg
RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • On stable doses of atorvastatin (40 mg daily) for 45 days prior to Day 1.
  • BMI 18.5 to 40 kg/m2 inclusive, and body weight equal or lower than 150 kg.

Exclusion Criteria:

  • History of a cardiovascular event (e.g., MI ) during the past year.
  • Poorly controlled Type 1 or Type 2 Diabetes mellitus (definition: uncontrolled diabetes is defined as HBIAc >9%).
  • Poorly controlled hypertension (uncontrolled hypertension is defined as a systolic blood pressure greater than 140 mm Hg or a diastolic blood pressure greater than 90 mm Hg, even with treatment). Subjects who have hypertension and are controlled on stable dosages of anti-hypertensive medications can be included.
  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: NCT01163851

Locations
United States, Arizona
Pfizer Investigational Site
Phoenix, Arizona, United States, 85013
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
Pfizer Investigational Site
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01163851     History of Changes
Other Study ID Numbers: B1481003
Study First Received: July 14, 2010
Last Updated: June 17, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Hypercholesterolemia
Dyslipidemia
LDL
Cholesterol
High Cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Dyslipidemias
Hyperlipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 21, 2014