Safety Study of BMS-823778 in Subjects With Hypercholesterolemia

A Double-Blind, Placebo-Controlled, Parallel-Group, Randomized, Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effects of BMS-823778 in Non-Diabetic Subjects With Primary Hypercholesterolemia on a Stable Dose of Statin Therapy With or Without Ezetimibe

The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)

Study Overview

• Status: Completed
• Conditions: Dyslipidemia
• Intervention / Treatment: Drug: BMS-823778; Drug: BMS-823778; Drug: BMS-823778; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4021
      • Local Institution
• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2V 4W3
      • Local Institution
  • Newfoundland and Labrador
    • Mount Pearl, Newfoundland and Labrador, Canada, A1N 1W7
      • Local Institution
  • Ontario
    • London, Ontario, Canada, N6A 5R8
      • Local Institution
  • Quebec
    • Drummondville, Quebec, Canada, J2B 7T1
      • Local Institution
    • Montreal, Quebec, Canada, H3J 2V5
      • Local Institution
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72201
      • Osborne Research Center
  • Kansas
    • Lenexa, Kansas, United States, 66219
      • PRA International
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Sterling Research Grp, Ltd.
  • Texas
    • San Antonio, Texas, United States, 78229
      • Cetero Research - San Antonio
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • National Clinical Research - Norfolk, Inc.
    • Richmond, Virginia, United States, 23294
      • National Clinical Research - Richmond, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Hypercholesterolemia
• Currently taking a stable daily dose of statin therapy
• Serum triglyceride level < 500mg/dl

Exclusion Criteria:

• History of myocardial infarction, coronary angioplasty or bypass grafts, valvular disease or repair, unstable angina pectoris, transient ischemic attack, or cerebrovascular accidents within six months prior to entry into the study
• Congestive heart failure
• Diabetes mellitus
• Active liver disease
• Impaired renal function
• Hepatitis C, B and HIV

This list is not inclusive; additional information is provided in the protocol

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Capsules, Oral, 0 mg, once daily, 28 days
Experimental: BMS-823778 (2 mg)	Drug: BMS-823778; Capsules, Oral, 2 mg, once daily, 28 days; Drug: BMS-823778; Capsules, Oral, 10 mg, once daily, 28 days; Drug: BMS-823778; Capsules, Oral, 20 mg, once daily, 28 days
Experimental: BMS-823778 (10 mg)	Drug: BMS-823778; Capsules, Oral, 2 mg, once daily, 28 days; Drug: BMS-823778; Capsules, Oral, 10 mg, once daily, 28 days; Drug: BMS-823778; Capsules, Oral, 20 mg, once daily, 28 days
Experimental: BMS-823778 (20 mg)	Drug: BMS-823778; Capsules, Oral, 2 mg, once daily, 28 days; Drug: BMS-823778; Capsules, Oral, 10 mg, once daily, 28 days; Drug: BMS-823778; Capsules, Oral, 20 mg, once daily, 28 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Lowering of LDL-C	Within 28 days following dosing

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (measuring trough concentrations)	On days 7, 14, and 28
Pharmacodynamic effects of BMS-823778 on Total cholesterol, HDL-C, Triglycerides, non-HDL-C, free fatty acids, Apolipoprotein fractions, HPA axis marker and free testosterone and sex hormone binding globulin (SHBG)	Within 28 days following dosing

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Actual): December 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: April 23, 2010
• First Submitted That Met QC Criteria: April 27, 2010
• First Posted (Estimate): April 28, 2010

Study Record Updates

• Last Update Posted (Estimate): October 12, 2015
• Last Update Submitted That Met QC Criteria: September 23, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: MB121-003