Safety Study of BMS-844421 for Treatment of Hypercholesterolemia

• Status: Terminated
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Pharmaceutical Solutions

Criteria

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