A Phase 1 interventional study of BMS-852927 and BMS-852927 in Hypercholesterolemia, sponsored by Bristol-Myers Squibb. Terminated at 8 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-08-05.
Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment
The purpose of this study is to evaluate the safety of BMS-852927 after 28 days of dosing in patients with high cholesterol.
1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.
This study's enrollment of 97 is close to the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.
Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: BMS-852927
Drug: BMS-852927
Drug: BMS-852927
Drug: Placebo
Capsules, Oral, 0.25 mg, Once daily, 28 days
Capsules, Oral, 1.0 mg, Once daily, 28 days
Capsules, Oral, 2.5 mg, Once daily, 28 days
Capsules, Oral, 0 mg, Once daily, 28 days
Number and percent of subjects that experience the Serious adverse events, Deaths, Adverse events leading to discontinuation of study therapy
Time frame: 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
Time frame: 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
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
Time frame: Upto 56 days
Number and percent of subjects with potentially clinically significant changes in low density lipoprotein (LDL)-c (measured)
LDL-c (measured) defined as: * LDL-c (mg/dL): LDL-c percent changes from baseline \>= 15%
Time frame: Upto 56 days
Trough observed concentration (Cmin) of BMS-852927 will be derived from plasma concentration versus time data
Time frame: 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
Time frame: Days 1 and 28
This study is terminated, as verified in Aug 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Bristol-Myers Squibb