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Safety Study of BMS-844421 for Treatment of Hypercholesterolemia

Primary Purpose

Atherosclerosis, Hypercholesterolemia

Status

Terminated

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

BMS-844421

0.9% sodium chloride injection solution

About this trial

This is an interventional treatment trial for Atherosclerosis

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts 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

Sites / Locations

Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm 14

Arm 15

Arm 16

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Arm 1 - BMS-844421

Arm 2 - 0.9% sodium chloride injection solution

Arm 3 - BMS-844421

Arm 4 - 0.9% sodium chloride injection solution

Arm 5 - BMS-844421

Arm 6 - 0.9% sodium chloride injection solution

Arm 7 - BMS-844421

Arm 8 - 0.9% sodium chloride injection solution

Arm 9 - BMS-844421

Arm 10 - 0.9% sodium chloride injection solution

Arm 11 - BMS-844421

Arm 12 - 0.9% sodium chloride injection solution

Arm 13 - BMS-844421

Arm 14 - 0.9% sodium chloride injection solution

Arm 15 - BMS-844421

Arm 16 - 0.9% sodium chloride injection solution

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Assess single and multiple dose pharmacokinetics of BMS-844421

Assess the absolute bioavailability of single BMS-844421 SC doses

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

Full Information

NCT ID

NCT01082562

First Posted

March 5, 2010

Last Updated

January 25, 2011

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT01082562

Brief Title

Safety Study of BMS-844421 for Treatment of Hypercholesterolemia

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2011

Overall Recruitment Status

Terminated

Study Start Date

April 2010 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

July 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis, Hypercholesterolemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 - BMS-844421

Arm Type

Experimental

Arm Title

Arm 2 - 0.9% sodium chloride injection solution

Arm Type

Placebo Comparator

Arm Title

Arm 3 - BMS-844421

Arm Type

Experimental

Arm Title

Arm 4 - 0.9% sodium chloride injection solution

Arm Type

Placebo Comparator

Arm Title

Arm 5 - BMS-844421

Arm Type

Experimental

Arm Title

Arm 6 - 0.9% sodium chloride injection solution

Arm Type

Placebo Comparator

Arm Title

Arm 7 - BMS-844421

Arm Type

Experimental

Arm Title

Arm 8 - 0.9% sodium chloride injection solution

Arm Type

Placebo Comparator

Arm Title

Arm 9 - BMS-844421

Arm Type

Experimental

Arm Title

Arm 10 - 0.9% sodium chloride injection solution

Arm Type

Placebo Comparator

Arm Title

Arm 11 - BMS-844421

Arm Type

Experimental

Arm Title

Arm 12 - 0.9% sodium chloride injection solution

Arm Type

Placebo Comparator

Arm Title

Arm 13 - BMS-844421

Arm Type

Experimental

Arm Title

Arm 14 - 0.9% sodium chloride injection solution

Arm Type

Placebo Comparator

Arm Title

Arm 15 - BMS-844421

Arm Type

Experimental

Arm Title

Arm 16 - 0.9% sodium chloride injection solution

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

BMS-844421

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

0.9% sodium chloride injection solution

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

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

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution

City

Berlin

ZIP/Postal Code

14050

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Safety Study of BMS-844421 for Treatment of Hypercholesterolemia

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