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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Panel 1: BMS-823778 or Placebo matching BMS-823778 | Experimental | Healthy Subjects |
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| Panel 2: BMS-823778 or Placebo matching BMS-823778 | Experimental | Healthy Subjects |
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| Panel 3: BMS-823778 or Placebo matching BMS-823778 | Experimental | Healthy Subjects |
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| Panel 4: BMS-823778 or Placebo matching BMS-823778 | Experimental | Subjects with T2DM |
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| Panel 5: BMS-823778 or Placebo matching BMS-823778 | Experimental | Subjects with T2DM |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-823778 | Drug | Capsules, Oral, 2 mg, Once daily, 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Hachioji-Shi | Tokyo | 1920071 | Japan |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C000624964 | BMS-823778 |
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| BMS-823778 | Drug | Capsules, Oral, 12 mg, Once daily, 14 days |
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| BMS-823778 | Drug | Capsules, Oral, 25 mg, Once daily, 14 days |
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| BMS-823778 | Drug | Capsules, Oral, 15 mg, Once daily, 14 days |
|
| Placebo matching with BMS-823778 | Drug | Capsules, Oral, 0 mg, Once daily, 14 days |
|
| 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) |
| Up to Day 21 |
| D004700 | Endocrine System Diseases |