Safety Study of BMS-844421 for Treatment of Hypercholesterolemia

Phase 1TerminatedNCT01082562

Bristol-Myers Squibb40 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atherosclerosis Hypercholesterolemia

Interventions

BMS-844421DRUG

Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days

0.9% sodium chloride injection solutionDRUG

Injection solution, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Berlin, Germany

Outcomes

Primary Outcomes

To asses safety, tolerability, pharmacodynamic effects of BMS-844421 on PCSK9 concentrations

Time frame: At the conclusion of the MAD part of the study

Secondary Outcomes

Assess single and multiple dose pharmacokinetics of BMS-844421

Time frame: All outcomes will be assessed at the conclusion of the MAD part of the study

Assess the absolute bioavailability of single BMS-844421 SC doses

Time frame: All outcomes will be assessed at the conclusion of the MAD part of the study

Assess the effects of multiple doses of BMS-844421on lipid components

Time frame: All outcomes will be assessed at the conclusion of the MAD part of the study

Data from ClinicalTrials.gov

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