A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia

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

Official Title
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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

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: BMS-852927
* Drug: BMS-852927
* Drug: BMS-852927
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: BMS-852927 (0.25 mg)<br> | Drug: BMS-852927<br>* Capsules, Oral, 0.25 mg, Once daily, 28 days<br>|
| Experimental: Arm 2: BMS-852927 (1.0 mg)<br> | Drug: BMS-852927<br>* Capsules, Oral, 1.0 mg, Once daily, 28 days<br>|
| Experimental: Arm 3: BMS-852927 (2.5 mg)<br> | Drug: BMS-852927<br>* Capsules, Oral, 2.5 mg, Once daily, 28 days<br>|
| Placebo Comparator: Arm 4: Placebo<br> | Drug: Placebo<br>* Capsules, Oral, 0 mg, Once daily, 28 days<br>|

What is the study measuring?
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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 | Measure Description | 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 |