A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01651273

Enrollment

Registered

2012-07-27

Start date

2012-11-30

Completion date

2013-06-30

Last updated

2013-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

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.

Interventions

DRUGBMS-852927

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

DRUGPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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 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

Measure	Time frame
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

Countries

Canada, Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026