NCT01082562

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2010

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

January 26, 2011

Status Verified

January 1, 2011

Enrollment Period

3 months

First QC Date

March 5, 2010

Last Update Submit

January 25, 2011

Conditions

AtherosclerosisHypercholesterolemia

Outcome Measures

Primary Outcomes (1)

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

    At the conclusion of the MAD part of the study

Secondary Outcomes (3)

  • 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 absolute bioavailability of single BMS-844421 SC doses

    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

Study Arms (16)

Arm 1 - BMS-844421

EXPERIMENTAL
Drug: BMS-844421

Arm 2 - 0.9% sodium chloride injection solution

PLACEBO COMPARATOR
Drug: 0.9% sodium chloride injection solution

Arm 3 - BMS-844421

EXPERIMENTAL
Drug: BMS-844421

Arm 4 - 0.9% sodium chloride injection solution

PLACEBO COMPARATOR
Drug: 0.9% sodium chloride injection solution

Arm 5 - BMS-844421

EXPERIMENTAL
Drug: BMS-844421

Arm 6 - 0.9% sodium chloride injection solution

PLACEBO COMPARATOR
Drug: 0.9% sodium chloride injection solution

Arm 7 - BMS-844421

EXPERIMENTAL
Drug: BMS-844421

Arm 8 - 0.9% sodium chloride injection solution

PLACEBO COMPARATOR
Drug: 0.9% sodium chloride injection solution

Arm 9 - BMS-844421

EXPERIMENTAL
Drug: BMS-844421

Arm 10 - 0.9% sodium chloride injection solution

PLACEBO COMPARATOR
Drug: 0.9% sodium chloride injection solution

Arm 11 - BMS-844421

EXPERIMENTAL
Drug: BMS-844421

Arm 12 - 0.9% sodium chloride injection solution

PLACEBO COMPARATOR
Drug: 0.9% sodium chloride injection solution

Arm 13 - BMS-844421

EXPERIMENTAL
Drug: BMS-844421

Arm 14 - 0.9% sodium chloride injection solution

PLACEBO COMPARATOR
Drug: 0.9% sodium chloride injection solution

Arm 15 - BMS-844421

EXPERIMENTAL
Drug: BMS-844421

Arm 16 - 0.9% sodium chloride injection solution

PLACEBO COMPARATOR
Drug: 0.9% sodium chloride injection solution

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

Arm 1 - BMS-844421Arm 11 - BMS-844421Arm 13 - BMS-844421Arm 15 - BMS-844421Arm 3 - BMS-844421Arm 5 - BMS-844421Arm 7 - BMS-844421Arm 9 - BMS-844421
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

Arm 10 - 0.9% sodium chloride injection solutionArm 12 - 0.9% sodium chloride injection solutionArm 14 - 0.9% sodium chloride injection solutionArm 16 - 0.9% sodium chloride injection solutionArm 2 - 0.9% sodium chloride injection solutionArm 4 - 0.9% sodium chloride injection solutionArm 6 - 0.9% sodium chloride injection solutionArm 8 - 0.9% sodium chloride injection solution

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Local Institution

Berlin, 14050, Germany

Location

Related Links

MeSH Terms

Conditions

AtherosclerosisHypercholesterolemia

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesHyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 5, 2010

First Posted

March 8, 2010

Study Start

April 1, 2010

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

January 26, 2011

Record last verified: 2011-01

Locations

DE(1)