Safety Study of BMS-844421 for Treatment of Hypercholesterolemia

This study has been terminated.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01082562
First received: March 5, 2010
Last updated: January 25, 2011
Last verified: January 2011
  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:


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 Bristol-Myers Squibb
  More Information

Additional Information:
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 April 16, 2014