A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia

• ClinicalTrials.gov Identifier: NCT01651273
• Recruitment Status: Terminated
• First Posted: July 27, 2012
• Last Update Posted: August 5, 2013
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

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.

Condition or disease	Intervention/treatment	Phase
Hypercholesterolemia	Drug: BMS-852927; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 97 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, 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
• Study Start Date: November 2012
• Actual Primary Completion Date: June 2013
• Actual Study Completion Date: June 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. 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 ]
3. Number and percent of subjects with potentially clinically significant changes in ECG parameter [ Time Frame: Upto 56 days ]

   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
4. Number and percent of subjects with potentially clinically significant changes in low density lipoprotein (LDL)-c (measured) [ Time Frame: Upto 56 days ]

   LDL-c (measured) defined as:

   • LDL-c (mg/dL): LDL-c percent changes from baseline >= 15%

Secondary Outcome Measures :

1. Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data [ Time Frame: Days 7, 14, 21 and 28 ]
2. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

Canada, Ontario

Local Institution

Brampton, Ontario, Canada, L6T 0G1

Local Institution

Toronto, Ontario, Canada, M4G 3E8

Canada, Quebec

Local Institution

Pointe-Claire, Quebec, Canada, H9R 4S3

Local Institution

Victoriaville, Quebec, Canada, G6P 6P6

Canada

Local Institution

Quebec, Canada, G1N 4V3

Local Institution

Quebec, Canada, G3K 2P8

Germany

Local Institution

Berlin, Germany, 10117

Local Institution

Neuss, Germany, 41460

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

More Information

Additional Information:

BMS clinical trial educational resource 

Investigator Inquiry form 

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT01651273
• Other Study ID Numbers: CV201-008; 2012-001946-17 ( EudraCT Number )
• First Posted: July 27, 2012
• Last Update Posted: August 5, 2013
• Last Verified: August 2013

Additional relevant MeSH terms:

Hypercholesterolemia; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases