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Clinical Trial Details

Trial ID: L4999
Source ID: NCT01515202
Associated Drug: Bms-823778
Title: Japanese Phase 1 Multiple Ascending Dose Study
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: BMS-823778|DRUG: BMS-823778|DRUG: BMS-823778|DRUG: BMS-823778|DRUG: Placebo matching with BMS-823778
Outcome Measures: Primary: Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests, Up to Day 21 | Secondary: Maximum observed plasma concentration (Cmax) of BMS-823778, as measured by plasma/urine concentration, Up to Day 21|Trough observed plasma concentration (Cmin) of BMS-823778, as measured by plasma/urine concentration, Up to Day 21|Time of maximum observed plasma concentration (Tmax) of BMS-823778, as measured by plasma/urine concentration, Up to Day 21|Area under the plasma concentration-time curve in one dosing interval [AUC(TAU)] of BMS-823778, as measured by plasma/urine concentration, Up to Day 21|Accumulation Index following multiple dosing (AI) of BMS-823778, as measured by plasma/urine concentration, Up to Day 21|Plasma half-life (T-HALF) of BMS-823778, as measured by plasma/urine concentration, Up to Day 21|Percent urinary recovery (% UR) of BMS-823778, as measured by plasma/urine concentration, Up to Day 21|Apparent total body clearance (CLT/F) of BMS-823778, as measured by plasma/urine concentration, Up to Day 21|Renal clearance from plasma (CLR) of BMS-823778, as measured by plasma/urine concentration, Up to Day 21|Peak to trough ratio (Cmax/Cmin) of BMS-823778, as measured by plasma/urine concentration, Up to Day 21|Effective plasma half-life (T-HALFeff) of BMS-823778, as measured by plasma/urine concentration, Up to Day 21|Pharmacodynamics, as measured by Serum concentration of cortisol and cortisone after an oral dose of cortisone and biomarkers for HPA axis activity (urinary free cortisol and cortisone, salivary cortisol, ACTH, DHEA-S and 4-androstenedione), * HPA = Hypothalamic-pituitary-adrenal * DHEA-S = Dehydroepiandrosterone-sulphate * ACTH = adrenocorticotropic hormone, Up to Day 21
Sponsor/Collaborators: Sponsor: Bristol-Myers Squibb
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1
Enrollment: 40
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2012-03
Completion Date: 2012-09
Results First Posted:
Last Update Posted: 2012-12-05
Locations: Local Institution, Hachioji-Shi, Tokyo, 1920071, Japan
URL: https://clinicaltrials.gov/show/NCT01515202