| Trial ID: | L2749 |
| Source ID: | NCT01240980
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| Associated Drug: |
Bms-903452
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| Title: |
Safety Study of BMS-903452 in Healthy Subjects (Panel 1-7) & Relative Bioavailability of the Crystalline and Amorphous Forms of BMS-903452 [Panels 4, 6, 11 & 12(Part A)], and Subjects With Type 2 Diabetes Mellitus (Part B)
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
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| Conditions: |
Diabetes
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| Interventions: |
DRUG: BMS-903452|DRUG: BMS-903452|DRUG: BMS-903452|DRUG: BMS-903452|DRUG: BMS-903452|DRUG: BMS-903452|DRUG: BMS-903452|DRUG: Placebo|DRUG: Placebo|DRUG: BMS-903452|DRUG: BMS-903452|DRUG: Placebo|DRUG: BMS-903452|DRUG: BMS-903452|DRUG: BMS-903452
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| Outcome Measures: |
Primary: Safety and Tolerability of the investigational drug, as assessed by adverse event monitoring, physical examinations, clinical laboratory determinations, electrocardiograms (ECG), and vital sign assessments, Within 10 days of study drug administration | Secondary: Pharmacodynamic activity of the investigational drug on glucose and hormones regulating glucose metabolism, Within 2 days of study drug administration|Effect on electrocardiographic (ECG) parameters, Within 10 days of study drug administration|Percent urinary recovery (% UR), derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses, Within 10 days of study drug administration|Renal clearance (CLR) from plasma, derived by non-compartmental methods by a validated pharmacokinetic program. Actual times will be used for the analyses, Within 10 days of study drug administration|The single-dose pharmacokinetics parameter maximum observed concentration in plasma (Cmax) of BMS-903452 will be derived from the plasma concentration versus time data, Within 10 days after study drug administration|The single-dose pharmacokinetics parameter time to reach maximum observed concentration in plasma (Tmax) of BMS-903452 will be derived from the plasma concentration versus time data, Within 10 days after study drug administration|The single-dose pharmacokinetics parameter time Area under the plasma concentration-time curve from time zero extrapolated to infinity AUC(INF) of BMS-903452 will be derived from the plasma concentration versus time data, Within 10 days after study drug administration|The single-dose pharmacokinetics parameter Area under the plasma concentration-time curve from time zero to last measurable sampling time AUC (0-T) of BMS-903452 will be derived from the plasma concentration versus time data, Within 10 days after study drug administration|The single-dose pharmacokinetics parameter Terminal-phase elimination half-life in plasma (T-Half) of BMS-903452 will be derived from the plasma concentration versus time data, Within 10 days after study drug administration|The single-dose pharmacokinetics parameter apparent clearance from plasma after extra-vascular administration (CLT/F) of BMS-903452 will be derived from the plasma concentration versus time data, Within 10 days after study drug administration
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| Sponsor/Collaborators: |
Sponsor: Bristol-Myers Squibb
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE1
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| Enrollment: |
104
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| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
2010-11
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| Completion Date: |
2012-01
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| Results First Posted: |
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| Last Update Posted: |
2012-03-15
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| Locations: |
Comprehensive Phase One, Miramar, Florida, 33025, United States|Ppd Development, Lp, Austin, Texas, 78744, United States
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| URL: |
https://clinicaltrials.gov/show/NCT01240980
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