Safety Study of BMS-844421 for Treatment of Hypercholesterolemia

Atherosclerosis Clinical Trial

Official title:

Randomized, Double-blind, Placebo-Controlled, Ascending Single- and Multiple-Dose Study to Evaluate the Safety , Pharmacokinetics and Pharmacodynamics of BMS-844421 in Healthy Subjects and in Subjects With Elevated Cholesterol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01082562
• Other study ID #: CV198-002
• Secondary ID: 2009-012032-32
• Status: Terminated
• Phase: Phase 1
• First received: March 5, 2010
• Last updated: January 25, 2011
• Start date: April 2010
• Est. completion date: July 2010

Study information

• Verified date: January 2011
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Hypercholesterolemia

Intervention

Drug:
• BMS-844421
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 solution
Injection solution, Subcutaneous, 37.5 mg SAD: Once, 1 Day MAD: IV loading followed by 4 weekly doses, 29 Days

Locations

Country	Name	City	State
Germany	Local Institution	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To asses safety, tolerability, pharmacodynamic effects of BMS-844421 on PCSK9 concentrations		At the conclusion of the MAD part of the study	No
Secondary	Assess single and multiple dose pharmacokinetics of BMS-844421		All outcomes will be assessed at the conclusion of the MAD part of the study	No
Secondary	Assess the absolute bioavailability of single BMS-844421 SC doses		All outcomes will be assessed at the conclusion of the MAD part of the study	No
Secondary	Assess the effects of multiple doses of BMS-844421on lipid components		All outcomes will be assessed at the conclusion of the MAD part of the study	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form