Multiple-Dose Safety Study Of RN316 For TheTreatment Of Hypercholesterolemia
This study has been withdrawn prior to enrollment.
(Study was redesigned based on FDA feedback.)
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01163838
First received: July 14, 2010
Last updated: September 13, 2010
Last verified: September 2010
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Purpose
The primary objective of this study is to evaluate the safety and tolerability of repeated doses of RN316 in eligible healthy volunteers. RN316 is an investigational drug that is currently being studied as a cholesterol lowering therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypercholesterolemia Dyslipidemia |
Biological: Placebo Biological: 1 mg/kg every 2 weeks Biological: 2 mg/kg every 4 weeks Biological: 4 mg/kg every 4 weeks Biological: 4 mg/kg every 8 weeks Biological: 8 mg/kg every 8 weeks Biological: 12 mg/kg every 8 weeks |
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 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: Every Scheduled Visit ] [ Designated as safety issue: Yes ]
- Incidence, severity and causal relationship of treatment emergent AEs (TEAEs). [ Time Frame: Every Scheduled Visit ] [ Designated as safety issue: Yes ]
- Incidence of abnormal and clinically relevant safety laboratories. [ Time Frame: Screening and Days 29, 57, 85, 113, 135, 141, 169 and 197 ] [ Designated as safety issue: Yes ]
- Abnormal and clinically relevant changes in vital signs, BP, and ECG parameters. [ Time Frame: Every Scheduled Visit ] [ Designated as safety issue: Yes ]
- Incidence of anti-drug-antibodies. [ Time Frame: Baseline and Day 15 and monthly thereafter ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- PK parameter estimates including but not be limited to: AUC, Tmax, Cmax terminal elimination half life (t1/2), Clearance (CL), volume of distribution at steady state (Vss), and accumulation ratio (R) of RN316. [ Time Frame: Day 1 and every scheduled visit thereafter ] [ Designated as safety issue: No ]
- Absolute and percentage change in LDL C from baseline. [ Time Frame: Every scheduled visit except Day 1 ] [ Designated as safety issue: No ]
- Proportion of subjects who achieve a target LDL C of <100 mg/mL. [ Time Frame: Every scheduled visit except Day 1 ] [ Designated as safety issue: No ]
- Proportion of subjects who achieve a target LDL C of <70 mg/dL. [ Time Frame: Every scheduled visit except Day 1 ] [ Designated as safety issue: No ]
- Proportion of subjects achieving 50% decrease in LDL C from baseline. [ Time Frame: Every scheduled visit except Day 1 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 91 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: Placebo |
Biological: Placebo
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
|
| Experimental: RN316: 1 mg/kg every 2 weeks |
Biological: 1 mg/kg every 2 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
|
| Experimental: RN316: 2 mg/kg every 4 weeks |
Biological: 2 mg/kg every 4 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
|
| Experimental: RN316: 4 mg/kg every 4 weeks |
Biological: 4 mg/kg every 4 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
|
| Experimental: RN316: 4 mg/kg every 8 weeks |
Biological: 4 mg/kg every 8 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
|
| Experimental: RN316: 8 mg/kg every 8 weeks |
Biological: 8 mg/kg every 8 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
|
| Experimental: RN316: 12 mg/kg every 8 weeks |
Biological: 12 mg/kg every 8 weeks
Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
|
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- LDL-C must be greater or equal to 130 mg/dl
- BMI must be between 18.5 and 40 kg/m2
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 More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT01163838 History of Changes |
| Other Study ID Numbers: | B1481002 |
| Study First Received: | July 14, 2010 |
| Last Updated: | September 13, 2010 |
| 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 |
ClinicalTrials.gov processed this record on May 23, 2013