NCT01651273

Brief Summary

The purpose of this study is to evaluate the safety of BMS-852927 after 28 days of dosing in patients with high cholesterol.

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
97

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_1

Geographic Reach
2 countries

8 active sites

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

July 13, 2012

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 27, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

August 5, 2013

Status Verified

August 1, 2013

Enrollment Period

7 months

First QC Date

July 13, 2012

Last Update Submit

August 2, 2013

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (4)

  • Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy

    Up to 56 days of study participation

  • Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy

    Up to 30 days post discontinuation of dosing or last participation in the study for serious adverse events collection

  • Number and percent of subjects with potentially clinically significant changes in ECG parameter

    Electrocardiogram (ECG) parameters defined as: * Investigator identified clinically significant abnormalities * QTcF\> 480 msec or QTcF changes from baseline\> 60 msec * QRS (msec): QRS\> 120 msec * PR (msec): PR \> 210 msec

    Upto 56 days

  • Number and percent of subjects with potentially clinically significant changes in low density lipoprotein (LDL)-c (measured)

    LDL-c (measured) defined as: * LDL-c (mg/dL): LDL-c percent changes from baseline \>= 15%

    Upto 56 days

Secondary Outcomes (2)

  • Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data

    Days 7, 14, 21 and 28

  • Area under the concentration-time curve from zero (pre-dose) to 8 h [AUC(0-8h)] of BMS-852927 will be derived from plasma concentration versus time data

    Days 1 and 28

Study Arms (4)

Arm 1: BMS-852927 (0.25 mg)

EXPERIMENTAL
Drug: BMS-852927

Arm 2: BMS-852927 (1.0 mg)

EXPERIMENTAL
Drug: BMS-852927

Arm 3: BMS-852927 (2.5 mg)

EXPERIMENTAL
Drug: BMS-852927

Arm 4: Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BMS-852927DRUG

Capsules, Oral, 0.25 mg, Once daily, 28 days

Arm 1: BMS-852927 (0.25 mg)
PlaceboDRUG

Capsules, Oral, 0 mg, Once daily, 28 days

Arm 4: Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women, aged ≥18 to ≤75
  • Body mass index (BMI) ≤ 40 kg/m2
  • Primary hypercholesterolemia on a stable daily dose of a statin for ≥ 6 weeks
  • Serum triglyceride levels at screening \< 400mg/dL (\< 4.52 mmol/L)

You may not qualify if:

  • Any significant acute medical illness, significant cardiovascular history
  • Current or history of hepatic or hepatobiliary disease
  • Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Local Institution

Brampton, Ontario, L6T 0G1, Canada

Location

Local Institution

Toronto, Ontario, M4G 3E8, Canada

Location

Local Institution

Pointe-Claire, Quebec, H9R 4S3, Canada

Location

Local Institution

Québec, Quebec, G1N 4V3, Canada

Location

Local Institution

Québec, Quebec, G3K 2P8, Canada

Location

Local Institution

Victoriaville, Quebec, G6P 6P6, Canada

Location

Local Institution

Berlin, 10117, Germany

Location

Local Institution

Neuss, 41460, Germany

Location

Related Links

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid 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
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2012

First Posted

July 27, 2012

Study Start

November 1, 2012

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

August 5, 2013

Record last verified: 2013-08

Locations

CA(6)DE(2)