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A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia

This study is not yet open for participant recruitment.
Verified August 2012 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01651273
First received: July 13, 2012
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Hypercholesterolemia
 Drug: BMS-852927
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Number and percent of subjects with potentially clinically significant changes in ECG parameter [ Time Frame: Upto 56 days ] [ Designated as safety issue: Yes ]

    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) [ Time Frame: Upto 56 days ] [ Designated as safety issue: Yes ]

    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 [ Time Frame: Days 7, 14, 21 and 28 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 168
Study Start Date: August 2012
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: BMS-852927 (0.25 mg) Drug: BMS-852927
Capsules, Oral, 0.25 mg, Once daily, 28 days
Experimental: Arm 2: BMS-852927 (1.0 mg) Drug: BMS-852927
Capsules, Oral, 1.0 mg, Once daily, 28 days
Experimental: Arm 3: BMS-852927 (2.5 mg) Drug: BMS-852927
Capsules, Oral, 2.5 mg, Once daily, 28 days
Placebo Comparator: Arm 4: Placebo Drug: Placebo
Capsules, Oral, 0 mg, Once daily, 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651273

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01651273     History of Changes
Other Study ID Numbers: CV201-008, 2012‐001946‐17
Study First Received: July 13, 2012
Last Updated: August 9, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Canada: Health Canada
Switzerland: Swissmedic

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 19, 2013