The purpose of this clinical study is to assess the safety and tolerability of multiple oral doses of BMS-823778 in healthy Japanese subjects and Japanese patients with Type 2 Diabetes Mellitus.
MAD study - Multiple Ascending Dose study
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Capsules, Oral, 2 mg, Once daily, 14 days
Capsules, Oral, 12 mg, Once daily, 14 days
Capsules, Oral, 25 mg, Once daily, 14 days
Local Institution
Hachioji-Shi, Tokyo, Japan
Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
Time frame: Up to Day 21
Maximum observed plasma concentration (Cmax) of BMS-823778, as measured by plasma/urine concentration
Time frame: Up to Day 21
Trough observed plasma concentration (Cmin) of BMS-823778, as measured by plasma/urine concentration
Time frame: Up to Day 21
Time of maximum observed plasma concentration (Tmax) of BMS-823778, as measured by plasma/urine concentration
Time frame: 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
Time frame: Up to Day 21
Accumulation Index following multiple dosing (AI) of BMS-823778, as measured by plasma/urine concentration
Time frame: Up to Day 21
Plasma half-life (T-HALF) of BMS-823778, as measured by plasma/urine concentration
Time frame: Up to Day 21
Percent urinary recovery (% UR) of BMS-823778, as measured by plasma/urine concentration
Time frame: Up to Day 21
Apparent total body clearance (CLT/F) of BMS-823778, as measured by plasma/urine concentration
Time frame: Up to Day 21
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Capsules, Oral, 15 mg, Once daily, 14 days
Capsules, Oral, 0 mg, Once daily, 14 days
Renal clearance from plasma (CLR) of BMS-823778, as measured by plasma/urine concentration
Time frame: Up to Day 21
Peak to trough ratio (Cmax/Cmin) of BMS-823778, as measured by plasma/urine concentration
Time frame: Up to Day 21
Effective plasma half-life (T-HALFeff) of BMS-823778, as measured by plasma/urine concentration
Time frame: 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
Time frame: Up to Day 21