A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia

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

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

Study Overview

• Status: Terminated
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Drug: BMS-852927; Drug: BMS-852927; Drug: BMS-852927; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G3K 2P8
    • Local Institution
  • Quebec, Canada, G1N 4V3
    • Local Institution
  • Ontario
    • Brampton, Ontario, Canada, L6T 0G1
      • Local Institution
    • Toronto, Ontario, Canada, M4G 3E8
      • Local Institution
  • Quebec
    • Pointe-Claire, Quebec, Canada, H9R 4S3
      • Local Institution
    • Victoriaville, Quebec, Canada, G6P 6P6
      • Local Institution
• Germany
  • Berlin, Germany, 10117
    • Local Institution
  • Neuss, Germany, 41460
    • Local Institution

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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: BMS-852927 (0.25 mg)	Drug: BMS-852927; Capsules, Oral, 0.25 mg, Once daily, 28 days; Drug: BMS-852927; Capsules, Oral, 1.0 mg, Once daily, 28 days; Drug: BMS-852927; Capsules, Oral, 2.5 mg, Once daily, 28 days
Experimental: Arm 2: BMS-852927 (1.0 mg)	Drug: BMS-852927; Capsules, Oral, 0.25 mg, Once daily, 28 days; Drug: BMS-852927; Capsules, Oral, 1.0 mg, Once daily, 28 days; Drug: BMS-852927; Capsules, Oral, 2.5 mg, Once daily, 28 days
Experimental: Arm 3: BMS-852927 (2.5 mg)	Drug: BMS-852927; Capsules, Oral, 0.25 mg, Once daily, 28 days; Drug: BMS-852927; Capsules, Oral, 1.0 mg, Once daily, 28 days; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy		Up to 56 days of study participation
Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy		Up to 30 days post discontinuation of dosing or last participation in the study for serious adverse events collection
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	Upto 56 days
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%	Upto 56 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data	Days 7, 14, 21 and 28
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	Days 1 and 28

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS clinical trial educational resource

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 13, 2012
• First Submitted That Met QC Criteria: July 26, 2012
• First Posted (Estimate): July 27, 2012

Study Record Updates

• Last Update Posted (Estimate): August 5, 2013
• Last Update Submitted That Met QC Criteria: August 2, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: CV201-008; 2012-001946-17 (EudraCT Number)