Clinical trial NCT01651273: A Safety Study of BMS-852927 in Subjects With Hypercholesterolemia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Hypercholesterolemia
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2012-07-27
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy
timeFrame: Up to 56 days of study participation
measure: Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy
timeFrame: Up to 30 days post discontinuation of dosing or last participation in the study for serious adverse events collection
measure: Number and percent of subjects with potentially clinically significant changes in ECG parameter
timeFrame: Upto 56 days
measure: Number and percent of subjects with potentially clinically significant changes in low density lipoprotein (LDL)-c (measured)
timeFrame: Upto 56 days
Secondary outcomes:
measure: Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data
timeFrame: Days 7, 14, 21 and 28
measure: 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
timeFrame: Days 1 and 28
Other outcomes:
Locations:
city: Brampton
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Pointe-Claire
country: Canada
facility: Local Institution
state: Quebec
city: Victoriaville
country: Canada
facility: Local Institution
state: Quebec
city: Quebec
country: Canada
facility: Local Institution
city: Quebec
country: Canada
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Neuss
country: Germany
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: