A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Hypercholesterolemia

Treatments: Drug: Placebo; Drug: BMS-852927

Study type: Interventional

Funder types: Industry

Identifiers

NCT01651273

2012-001946-17 (EudraCT Number)

CV201-008

Details and patient eligibility

About

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

Enrollment: 97 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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97 participants in 4 patient groups, including a placebo group

Arm 1: BMS-852927 (0.25 mg)

Experimental group

Treatment:

Drug: BMS-852927

Drug: BMS-852927

Drug: BMS-852927

Arm 2: BMS-852927 (1.0 mg)

Experimental group

Treatment:

Drug: BMS-852927

Drug: BMS-852927

Drug: BMS-852927

Arm 3: BMS-852927 (2.5 mg)

Experimental group

Treatment:

Drug: BMS-852927

Drug: BMS-852927

Drug: BMS-852927

Arm 4: Placebo

Placebo Comparator group

Treatment:

Drug: Placebo