A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1: BMS-852927 (0.25 mg)
|
Drug: BMS-852927
Capsules, Oral, 0.25 mg, Once daily, 28 days
|
| Experimental: Arm 2: BMS-852927 (1.0 mg)
|
Drug: BMS-852927
Capsules, Oral, 1.0 mg, Once daily, 28 days
|
| Experimental: Arm 3: BMS-852927 (2.5 mg)
|
Drug: BMS-852927
Capsules, Oral, 2.5 mg, Once daily, 28 days
|
| Placebo Comparator: Arm 4: Placebo
|
Drug: Placebo
Capsules, Oral, 0 mg, Once daily, 28 days
|
Outcome Measures
Primary Outcome Measures
- 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 [Upto 56 days]
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
- Number and percent of subjects with potentially clinically significant changes in low density lipoprotein (LDL)-c (measured) [Upto 56 days]
LDL-c (measured) defined as: LDL-c (mg/dL): LDL-c percent changes from baseline >= 15%
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Local Institution | Brampton | Ontario | Canada | L6T 0G1 |
| 2 | Local Institution | Toronto | Ontario | Canada | M4G 3E8 |
| 3 | Local Institution | Pointe-Claire | Quebec | Canada | H9R 4S3 |
| 4 | Local Institution | Victoriaville | Quebec | Canada | G6P 6P6 |
| 5 | Local Institution | Quebec | Canada | G1N 4V3 | |
| 6 | Local Institution | Quebec | Canada | G3K 2P8 | |
| 7 | Local Institution | Berlin | Germany | 10117 | |
| 8 | Local Institution | Neuss | Germany | 41460 |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- CV201-008
- 2012-001946-17