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
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: 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
Arteriosclerosis
Hypercholesterolemia
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014