A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia

Phase 1

Terminated

• Conditions: Hypercholesterolemia
• Interventions: Drug: BMS-852927; Drug: Placebo

• Registration Number: NCT01651273
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-13
• Study First Submitted QC: 2012-07-26
• Study First Posted: 2012-07-27
• Study Start: 2012-11
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-02
• Last Update Posted: 2013-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 97

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: BMS-852927 (0.25 mg)	BMS-852927	-
Arm 2: BMS-852927 (1.0 mg)	BMS-852927	-
Arm 3: BMS-852927 (2.5 mg)	BMS-852927	-
Arm 4: Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Local Institution; 🇩🇪 Neuss, Germany