Safety Study of BMS-844421 for Treatment of Hypercholesterolemia

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Hypercholesterolemia; Atherosclerosis

Treatments: Drug: BMS-844421; Drug: 0.9% sodium chloride injection solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT01082562

2009-012032-32 (EudraCT Number)

CV198-002

Details and patient eligibility

About

The purpose of this study is to assess the safety, tolerability, serum concentrations and pharmacodynamic effects on serum low-density lipoprotein (LDL) cholesterol of single and multiple subcutaneous and intravenous doses of BMS-844421 in healthy subjects (SAD) and in subjects with elevated cholesterol (MAD).

Enrollment: 40 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Subjects (SAD)
• Healthy Subjects (MAD) with untreated elevated cholesterol
• Body Mass Index (BMI) of 18 to 30 kg/m² inclusive
• Women who are not of childbearing potential and men, ages 18 to 45

Exclusion criteria

• Any significant acute or chronic medical illness
• History of liver or renal disorders
• Prior use of any prescription or over-the-counter lipid lowering drugs, within 8 weeks prior to study drug administration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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40 participants in 16 patient groups, including a placebo group

Arm 1 - BMS-844421

Experimental group

Treatment:

Drug: BMS-844421

Arm 2 - 0.9% sodium chloride injection solution

Placebo Comparator group

Treatment:

Drug: 0.9% sodium chloride injection solution

Arm 3 - BMS-844421

Experimental group

Treatment:

Drug: BMS-844421

Arm 4 - 0.9% sodium chloride injection solution

Placebo Comparator group

Treatment:

Drug: 0.9% sodium chloride injection solution

Arm 5 - BMS-844421

Experimental group

Treatment:

Drug: BMS-844421

Arm 6 - 0.9% sodium chloride injection solution

Placebo Comparator group

Treatment:

Drug: 0.9% sodium chloride injection solution

Arm 7 - BMS-844421

Experimental group

Treatment:

Drug: BMS-844421

Arm 8 - 0.9% sodium chloride injection solution

Placebo Comparator group

Treatment:

Drug: 0.9% sodium chloride injection solution

Arm 9 - BMS-844421

Experimental group

Treatment:

Drug: BMS-844421

Arm 10 - 0.9% sodium chloride injection solution

Placebo Comparator group

Treatment:

Drug: 0.9% sodium chloride injection solution

Arm 11 - BMS-844421

Experimental group

Treatment:

Drug: BMS-844421

Arm 12 - 0.9% sodium chloride injection solution

Placebo Comparator group

Treatment:

Drug: 0.9% sodium chloride injection solution

Arm 13 - BMS-844421

Experimental group

Treatment:

Drug: BMS-844421

Arm 14 - 0.9% sodium chloride injection solution

Placebo Comparator group

Treatment:

Drug: 0.9% sodium chloride injection solution

Arm 15 - BMS-844421

Experimental group

Treatment:

Drug: BMS-844421

Arm 16 - 0.9% sodium chloride injection solution

Placebo Comparator group

Treatment:

Drug: 0.9% sodium chloride injection solution