A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia

Phase 1TerminatedNCT01651273

Bristol-Myers Squibb97 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypercholesterolemia

Interventions

BMS-852927DRUG

Capsules, Oral, 0.25 mg, Once daily, 28 days

BMS-852927DRUG

Capsules, Oral, 1.0 mg, Once daily, 28 days

BMS-852927DRUG

Capsules, Oral, 2.5 mg, Once daily, 28 days

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (8)

Local Institution

Brampton, Ontario, Canada

Local Institution

Toronto, Ontario, Canada

Local Institution

Pointe-Claire, Quebec, Canada

Local Institution

Québec, Quebec, Canada

Outcomes

Primary Outcomes

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

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

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

Time frame: 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%

Time frame: Upto 56 days

Secondary Outcomes

Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data

Time frame: 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

Time frame: Days 1 and 28

Data from ClinicalTrials.gov

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