Safety Study of BMS-844421 for Treatment of Hypercholesterolemia

Phase 1

Terminated

• Conditions: Hypercholesterolemia; Atherosclerosis
• Interventions: Drug: 0.9% sodium chloride injection solution; Drug: BMS-844421

• Registration Number: NCT01082562
• Lead Sponsor: Bristol-Myers Squibb

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-03-05
• Study First Submitted QC: 2010-03-05
• Study First Posted: 2010-03-08
• Study Start: 2010-04
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-25
• Last Update Posted: 2011-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 4 - 0.9% sodium chloride injection solution	0.9% sodium chloride injection solution	-
Arm 8 - 0.9% sodium chloride injection solution	0.9% sodium chloride injection solution	-
Arm 2 - 0.9% sodium chloride injection solution	0.9% sodium chloride injection solution	-
Arm 3 - BMS-844421	BMS-844421	-
Arm 1 - BMS-844421	BMS-844421	-
Arm 6 - 0.9% sodium chloride injection solution	0.9% sodium chloride injection solution	-
Arm 10 - 0.9% sodium chloride injection solution	0.9% sodium chloride injection solution	-
Arm 11 - BMS-844421	BMS-844421	-
Arm 5 - BMS-844421	BMS-844421	-
Arm 7 - BMS-844421	BMS-844421	-
Arm 12 - 0.9% sodium chloride injection solution	0.9% sodium chloride injection solution	-
Arm 14 - 0.9% sodium chloride injection solution	0.9% sodium chloride injection solution	-
Arm 15 - BMS-844421	BMS-844421	-
Arm 9 - BMS-844421	BMS-844421	-
Arm 16 - 0.9% sodium chloride injection solution	0.9% sodium chloride injection solution	-
Arm 13 - BMS-844421	BMS-844421	-

Primary Outcome Measures

Name	Time	Method
To asses safety, tolerability, pharmacodynamic effects of BMS-844421 on PCSK9 concentrations	At the conclusion of the MAD part of the study

Secondary Outcome Measures

Name	Time	Method
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
Assess single and multiple dose pharmacokinetics of BMS-844421	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	All outcomes will be assessed at the conclusion of the MAD part of the study

Trial Locations

Locations (1)

Local Institution; 🇩🇪 Berlin, Germany