NCT01515202已完成1 期
A Randomized, Placebo-Controlled, Double-Blinded, Multiple Dose Escalation Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-823778 in Healthy Subjects and Patients With Type 2 Diabetes Mellitus
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
研究概览
简要总结
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.
详细描述
MAD study - Multiple Ascending Dose study
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Japanese patients with Type 2 Diabetes Mellitus (T2DM) [Fasting glucose < 240 mg/dL, Hemoglobin A1c (HbA1c): 6.5% to 10.0% National Glycohemoglobin Standardization Program (NGSP)] who are treatment-naive and managed with diet and/or exercises only, ages: 20 to 65 years
排除标准
- •Patient who is taking any medication for T2DM
- •Symptoms of poorly controlled diabetes that would preclude participation in this placebo-controlled trial
- •Insulin therapy within one year of screening
研究组 & 干预措施
Panel 4: BMS-823778 or Placebo matching BMS-823778
Experimental
Subjects with T2DM
干预措施: BMS-823778 (Drug)
Panel 1: BMS-823778 or Placebo matching BMS-823778
Experimental
Healthy Subjects
干预措施: BMS-823778 (Drug)
Panel 1: BMS-823778 or Placebo matching BMS-823778
Experimental
Healthy Subjects
干预措施: Placebo matching with BMS-823778 (Drug)
Panel 2: BMS-823778 or Placebo matching BMS-823778
Experimental
Healthy Subjects
干预措施: BMS-823778 (Drug)
Panel 2: BMS-823778 or Placebo matching BMS-823778
Experimental
Healthy Subjects
干预措施: Placebo matching with BMS-823778 (Drug)
Panel 3: BMS-823778 or Placebo matching BMS-823778
Experimental
Healthy Subjects
干预措施: BMS-823778 (Drug)
Panel 3: BMS-823778 or Placebo matching BMS-823778
Experimental
Healthy Subjects
干预措施: Placebo matching with BMS-823778 (Drug)
Panel 4: BMS-823778 or Placebo matching BMS-823778
Experimental
Subjects with T2DM
干预措施: Placebo matching with BMS-823778 (Drug)
Panel 5: BMS-823778 or Placebo matching BMS-823778
Experimental
Subjects with T2DM
干预措施: BMS-823778 (Drug)
Panel 5: BMS-823778 or Placebo matching BMS-823778
Experimental
Subjects with T2DM
干预措施: Placebo matching with BMS-823778 (Drug)
结局指标
主要结局
Safety and tolerability, as measured by the number, frequency and intensity of adverse events, vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
时间窗: Up to Day 21
次要结局
- 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)(Up to Day 21)
研究者
研究点 (1)
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