A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia

Hypercholesterolemia Clinical Trial

Official title:

A Site and Subject Blinded Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BMS 852927 in Patients With Primary Hypercholesterolemia on a Stable Dose of Statin Therapy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01651273
• Other study ID #: CV201-008
• Secondary ID: 2012-001946-17
• Status: Terminated
• Phase: Phase 1
• First received: July 13, 2012
• Last updated: August 2, 2013
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: August 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesCanada: Health CanadaSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 97
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Study Design

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• BMS-852927
Capsules, Oral, 0.25 mg, Once daily, 28 days
• BMS-852927
Capsules, Oral, 1.0 mg, Once daily, 28 days
• BMS-852927
Capsules, Oral, 2.5 mg, Once daily, 28 days
• Placebo
Capsules, Oral, 0 mg, Once daily, 28 days

Locations

Country	Name	City	State
Canada	Local Institution	Brampton	Ontario
Canada	Local Institution	Pointe-Claire	Quebec
Canada	Local Institution	Quebec
Canada	Local Institution	Quebec
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Victoriaville	Quebec
Germany	Local Institution	Berlin
Germany	Local Institution	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Canada,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data		Days 7, 14, 21 and 28	No
Secondary	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	No

External Links

•   BMS clinical trial educational resource
•   BMS Clinical Trial Information
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form