Pharmacokinetic And Pharmacodynamic Study Of A Single-Dose Of RN316 In Combination With Atorvastatin
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01163851
First received: July 14, 2010
Last updated: June 17, 2011
Last verified: June 2011
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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:
MedlinePlus related topics:
Cholesterol
Drug Information available for:
Atorvastatin calcium
U.S. FDA Resources
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
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 Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013