Safety Study of BMS-844421 for Treatment of Hypercholesterolemia - Full Text View

Purpose

The purpose of this study is to assess the safety, tolerability, serum concentrations and pharmacodynamic effects on serum low-density lipoprotein (LDL) cholesterol of single and multiple subcutaneous and intravenous doses of BMS-844421 in healthy subjects (SAD) and in subjects with elevated cholesterol (MAD).

Condition	Intervention	Phase
Atherosclerosis Hypercholesterolemia	Drug: BMS-844421 Drug: 0.9% sodium chloride injection solution	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Randomized, Double-blind, Placebo-Controlled, Ascending Single- and Multiple-Dose Study to Evaluate the Safety , Pharmacokinetics and Pharmacodynamics of BMS-844421 in Healthy Subjects and in Subjects With Elevated Cholesterol

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis Cholesterol

Drug Information available for: Sodium chloride Chlorine

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

To asses safety, tolerability, pharmacodynamic effects of BMS-844421 on PCSK9 concentrations [ Time Frame: At the conclusion of the MAD part of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assess single and multiple dose pharmacokinetics of BMS-844421 [ Time Frame: All outcomes will be assessed at the conclusion of the MAD part of the study ] [ Designated as safety issue: No ]
Assess the absolute bioavailability of single BMS-844421 SC doses [ Time Frame: All outcomes will be assessed at the conclusion of the MAD part of the study ] [ Designated as safety issue: No ]
Assess the effects of multiple doses of BMS-844421on lipid components [ Time Frame: All outcomes will be assessed at the conclusion of the MAD part of the study ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	April 2010
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 - BMS-844421	Drug: BMS-844421 Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days
Placebo Comparator: Arm 2 - 0.9% sodium chloride injection solution	Drug: 0.9% sodium chloride injection solution Injection solution, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days
Experimental: Arm 3 - BMS-844421	Drug: BMS-844421 Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days
Placebo Comparator: Arm 4 - 0.9% sodium chloride injection solution	Drug: 0.9% sodium chloride injection solution Injection solution, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days
Experimental: Arm 5 - BMS-844421	Drug: BMS-844421 Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days
Placebo Comparator: Arm 6 - 0.9% sodium chloride injection solution	Drug: 0.9% sodium chloride injection solution Injection solution, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days
Experimental: Arm 7 - BMS-844421	Drug: BMS-844421 Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days
Placebo Comparator: Arm 8 - 0.9% sodium chloride injection solution	Drug: 0.9% sodium chloride injection solution Injection solution, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days
Experimental: Arm 9 - BMS-844421	Drug: BMS-844421 Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days
Placebo Comparator: Arm 10 - 0.9% sodium chloride injection solution	Drug: 0.9% sodium chloride injection solution Injection solution, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days
Experimental: Arm 11 - BMS-844421	Drug: BMS-844421 Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days
Placebo Comparator: Arm 12 - 0.9% sodium chloride injection solution	Drug: 0.9% sodium chloride injection solution Injection solution, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days
Experimental: Arm 13 - BMS-844421	Drug: BMS-844421 Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days
Placebo Comparator: Arm 14 - 0.9% sodium chloride injection solution	Drug: 0.9% sodium chloride injection solution Injection solution, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days
Experimental: Arm 15 - BMS-844421	Drug: BMS-844421 Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days
Placebo Comparator: Arm 16 - 0.9% sodium chloride injection solution	Drug: 0.9% sodium chloride injection solution Injection solution, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy Subjects (SAD)
Healthy Subjects (MAD) with untreated elevated cholesterol
Body Mass Index (BMI) of 18 to 30 kg/m² inclusive
Women who are not of childbearing potential and men, ages 18 to 45

Exclusion Criteria:

Any significant acute or chronic medical illness
History of liver or renal disorders
Prior use of any prescription or over-the-counter lipid lowering drugs, within 8 weeks prior to study drug administration

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082562

Locations

Germany
Local Institution
Berlin, Germany, 14050

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

Investigator Inquiry form This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT01082562 History of Changes
Other Study ID Numbers:	CV198-002, 2009-012032-32
Study First Received:	March 5, 2010
Last Updated:	January 25, 2011
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:

Atherosclerosis
Hypercholesterolemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on June 17, 2013