The purpose of this study is to assess the safety, tolerability and pharmacodynamic effects on LDL cholesterol (LDL-C)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
Capsules, Oral, 2 mg, once daily, 28 days
Capsules, Oral, 10 mg, once daily, 28 days
Capsules, Oral, 20 mg, once daily, 28 days
Osborne Research Center
Little Rock, Arkansas, United States
Pra International
Lenexa, Kansas, United States
Sterling Research Grp, Ltd.
Cincinnati, Ohio, United States
Lowering of LDL-C
Time frame: Within 28 days following dosing
Pharmacokinetics (measuring trough concentrations)
Time frame: On days 7, 14, and 28
Pharmacodynamic effects of BMS-823778 on Total cholesterol, HDL-C, Triglycerides, non-HDL-C, free fatty acids, Apolipoprotein fractions, HPA axis marker and free testosterone and sex hormone binding globulin (SHBG)
Time frame: Within 28 days following dosing
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Capsules, Oral, 0 mg, once daily, 28 days
Cetero Research - San Antonio
San Antonio, Texas, United States
National Clinical Research - Norfolk, Inc.
Norfolk, Virginia, United States
National Clinical Research - Richmond, Inc.
Richmond, Virginia, United States
Local Institution
Brisbane, Queensland, Australia
Local Institution
Winnipeg, Manitoba, Canada
Local Institution
Mount Pearl, Newfoundland and Labrador, Canada
Local Institution
London, Ontario, Canada
...and 2 more locations