| Trial ID: | L5357 |
| Source ID: | NCT01290575
|
| Associated Drug: |
Placebo
|
| Title: |
Multiple Ascending Dose Study of BMS-820132 in Patients With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Placebo|DRUG: Placebo|DRUG: BMS-820132|DRUG: BMS-820132|DRUG: BMS-820132|DRUG: BMS-820132|DRUG: BMS-820132|DRUG: BMS-820132|DRUG: BMS-820132
|
| Outcome Measures: |
Primary: Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments., Throughout the study drug administration period (14 days)|Adverse events, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments., within 7 days after the final dose | Secondary: Maximum observed plasma concentration (Cmax) of BMS-820132, Day 1 and Day 14|Time of maximum observed plasma concentration (Tmax) of BMS-820132, Day 1 and Day 14|Trough observed plasma concentration (Cmin) of BMS-820132, Day 1 through Day 14 (selected days)|Area under the plasma concentration-time curve over one dosing interval [AUC(TAU)] of BMS-820132, Day 1 and Day 14|Accumulation index (AI) of BMS-820132, Day 14|Half life (T-Half) of BMS-820132, Day 14|AUC(0-24 h) and postprandial AUC(0-4h) for biomarkers of glucose homeostasis, Day -1, Day 1, Day 7 and Day 14
|
| Sponsor/Collaborators: |
Sponsor: Bristol-Myers Squibb
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1
|
| Enrollment: |
67
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2011-02
|
| Completion Date: |
2011-11
|
| Results First Posted: |
|
| Last Update Posted: |
2012-03-27
|
| Locations: |
Dedicated Phase I, Inc., Phoenix, Arizona, 85013, United States|Osborne Research Center, Little Rock, Arkansas, 72201, United States|Clinical Pharmacology Of Miami Inc., Miami, Florida, 33014, United States|Mra Clinical Research, Miami, Florida, 33143, United States|Cetero Research, San Antonio, Texas, 78229, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01290575
|
