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A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia

Primary Purpose

Hypercholesterolemia

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
BMS-852927
BMS-852927
BMS-852927
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Men and women, aged ≥18 to ≤75
  • Body mass index (BMI) ≤ 40 kg/m2
  • Primary hypercholesterolemia on a stable daily dose of a statin for ≥ 6 weeks
  • Serum triglyceride levels at screening < 400mg/dL (< 4.52 mmol/L)

Exclusion Criteria:

  • Any significant acute medical illness, significant cardiovascular history
  • Current or history of hepatic or hepatobiliary disease
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population

Sites / Locations

  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Arm 1: BMS-852927 (0.25 mg)

Arm 2: BMS-852927 (1.0 mg)

Arm 3: BMS-852927 (2.5 mg)

Arm 4: Placebo

Arm Description

Outcomes

Primary Outcome Measures

Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy
Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy
Number and percent of subjects with potentially clinically significant changes in ECG parameter
Electrocardiogram (ECG) parameters defined as: Investigator identified clinically significant abnormalities QTcF> 480 msec or QTcF changes from baseline> 60 msec QRS (msec): QRS> 120 msec PR (msec): PR > 210 msec
Number and percent of subjects with potentially clinically significant changes in low density lipoprotein (LDL)-c (measured)
LDL-c (measured) defined as: LDL-c (mg/dL): LDL-c percent changes from baseline >= 15%

Secondary Outcome Measures

Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data
Area under the concentration-time curve from zero (pre-dose) to 8 h [AUC(0-8h)] of BMS-852927 will be derived from plasma concentration versus time data

Full Information

First Posted
July 13, 2012
Last Updated
August 2, 2013
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01651273
Brief Title
A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia
Official Title
A Site and Subject Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS 852927 in Patients With Primary Hypercholesterolemia on a Stable Dose of Statin Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Study Start Date
November 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety of BMS-852927 after 28 days of dosing in patients with high cholesterol.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: BMS-852927 (0.25 mg)
Arm Type
Experimental
Arm Title
Arm 2: BMS-852927 (1.0 mg)
Arm Type
Experimental
Arm Title
Arm 3: BMS-852927 (2.5 mg)
Arm Type
Experimental
Arm Title
Arm 4: Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BMS-852927
Intervention Description
Capsules, Oral, 0.25 mg, Once daily, 28 days
Intervention Type
Drug
Intervention Name(s)
BMS-852927
Intervention Description
Capsules, Oral, 1.0 mg, Once daily, 28 days
Intervention Type
Drug
Intervention Name(s)
BMS-852927
Intervention Description
Capsules, Oral, 2.5 mg, Once daily, 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Capsules, Oral, 0 mg, Once daily, 28 days
Primary Outcome Measure Information:
Title
Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy
Time Frame
Up to 56 days of study participation
Title
Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy
Time Frame
Up to 30 days post discontinuation of dosing or last participation in the study for serious adverse events collection
Title
Number and percent of subjects with potentially clinically significant changes in ECG parameter
Description
Electrocardiogram (ECG) parameters defined as: Investigator identified clinically significant abnormalities QTcF> 480 msec or QTcF changes from baseline> 60 msec QRS (msec): QRS> 120 msec PR (msec): PR > 210 msec
Time Frame
Upto 56 days
Title
Number and percent of subjects with potentially clinically significant changes in low density lipoprotein (LDL)-c (measured)
Description
LDL-c (measured) defined as: LDL-c (mg/dL): LDL-c percent changes from baseline >= 15%
Time Frame
Upto 56 days
Secondary Outcome Measure Information:
Title
Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data
Time Frame
Days 7, 14, 21 and 28
Title
Area under the concentration-time curve from zero (pre-dose) to 8 h [AUC(0-8h)] of BMS-852927 will be derived from plasma concentration versus time data
Time Frame
Days 1 and 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Men and women, aged ≥18 to ≤75 Body mass index (BMI) ≤ 40 kg/m2 Primary hypercholesterolemia on a stable daily dose of a statin for ≥ 6 weeks Serum triglyceride levels at screening < 400mg/dL (< 4.52 mmol/L) Exclusion Criteria: Any significant acute medical illness, significant cardiovascular history Current or history of hepatic or hepatobiliary disease Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6T 0G1
Country
Canada
Facility Name
Local Institution
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4G 3E8
Country
Canada
Facility Name
Local Institution
City
Pointe-Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Local Institution
City
Victoriaville
State/Province
Quebec
ZIP/Postal Code
G6P 6P6
Country
Canada
Facility Name
Local Institution
City
Quebec
ZIP/Postal Code
G1N 4V3
Country
Canada
Facility Name
Local Institution
City
Quebec
ZIP/Postal Code
G3K 2P8
Country
Canada
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Local Institution
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource

Learn more about this trial

A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia

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