Safety Study of BMS-823778 in Subjects With Hypercholesterolemia

Phase 2

Completed

• Conditions: Dyslipidemia
• Interventions: Drug: BMS-823778; Drug: Placebo

• Registration Number: NCT01112423
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-04-23
• Study First Submitted QC: 2010-04-27
• Study First Posted: 2010-04-28
• Study Start: 2010-06
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Disposition First Submitted: 2012-04-25
• Status Verified: 2015-09
• Disposition First Submitted QC: 2015-09-23
• Last Update Submitted: 2015-09-23
• Disposition First Posted: 2015-10-12
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMS-823778 (2 mg)	BMS-823778	-
BMS-823778 (10 mg)	BMS-823778	-
BMS-823778 (20 mg)	BMS-823778	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Lowering of LDL-C	Within 28 days following dosing

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (7)

Pra International; 🇺🇸 Lenexa, Kansas, United States

Sterling Research Grp, Ltd.; 🇺🇸 Cincinnati, Ohio, United States

Osborne Research Center; 🇺🇸 Little Rock, Arkansas, United States

Cetero Research - San Antonio; 🇺🇸 San Antonio, Texas, United States

National Clinical Research - Richmond, Inc.; 🇺🇸 Richmond, Virginia, United States

National Clinical Research - Norfolk, Inc.; 🇺🇸 Norfolk, Virginia, United States

Local Institution; 🇨🇦 Montreal, Quebec, Canada