Phase 1, Randomized, Single-blind, Placebo-controlled Dose Escalation Study Evaluating Safety, Tolerability and Pharmacokinetics (PK) of JTT-251 Single Oral Doses in Healthy Subjects (Part Ia) and in Type 2 Diabetic Subjects (Part Ib) and Randomized, Open-label, Crossover Study Evaluating Effect of Food on PK in Healthy Subjects (Part II)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 主要终点
- fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval)
研究概览
简要总结
The purpose of this study is to evaluate the safety, tolerability, and PK (Pharmacokinetics) of single oral doses of JTT-251 in healthy and type 2 diabetes mellitus subjects and to evaluate the effect of food on the PK of JTT-251 in healthy subjects.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Subject Cohorts:
- •Healthy male or female subjects
- •Body Mass Index (BMI) between 19.0 and 31.0 kg/m2 (inclusive)
- •Type 2 Diabetic Subject Cohorts:
- •Male or female Type 2 diabetic subjects diagnosed for at least 3 months
- •BMI between 25 and 40 kg/m2 (inclusive)
- •Have a glycosylated hemoglobin (HbA1c) of >6.5% to ≤10.9% (inclusive) if treatment naïve with respect to hypoglycemic agents OR >6.5% to ≤10.0% (inclusive) if treated with metformin
排除标准
- •Healthy Subject Cohorts:
- •Known clinically relevant history or presence of significant respiratory, gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, metabolic, and dermatological or connective tissue disease
- •Subjects with a systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg
- •Type 2 Diabetic Subject Cohorts:
- •Subjects with a known medical history or presence of type 1 diabetes mellitus
- •Subjects with known medical history of acute metabolic diabetic complications
- •Subjects with uncontrolled hypertension (systolic blood pressure >160 mmHg and/or diastolic blood pressure >95 mmHg with documented ongoing treatment)
研究组 & 干预措施
Dose 4 JTT-251 or Placebo
Tablets, single dose in fed condition
干预措施: JTT-251 or Placebo (Drug)
Dose 1 JTT-251 or Placebo
Tablets, single dose in fed condition
干预措施: JTT-251 or Placebo (Drug)
Dose 2 JTT-251 or Placebo
Tablets, single dose in fed condition
干预措施: JTT-251 or Placebo (Drug)
Dose 3 JTT-251 or Placebo
Tablets, single dose in fed condition
干预措施: JTT-251 or Placebo (Drug)
Dose 5 JTT-251 or Placebo
Tablets, single dose in fed condition
干预措施: JTT-251 or Placebo (Drug)
Dose 6 JTT-251 or Placebo
Tablets, single dose in fed condition
干预措施: JTT-251 or Placebo (Drug)
Dose 7 JTT-251 or Placebo
Tablets, single dose in fed condition
干预措施: JTT-251 or Placebo (Drug)
Dose 8 JTT-251 or Placebo
Tablets, single dose in fed condition
干预措施: JTT-251 or Placebo (Drug)
Dose 9 JTT-251 or Placebo
Tablets, single dose in fasted or fed condition followed by a single dose in the alternate fed or fasted condition
干预措施: JTT-251 or Placebo (Drug)
结局指标
主要结局
fe(total) (fraction of systemically available drug excreted into the urine over entire collection interval)
时间窗: 1 week
Cmax (maximum concentration)
时间窗: 1 week
Vital signs and 12 lead ECGs
时间窗: 1 week
t1/2 (elimination half-life)
时间窗: 1 week
Number of subjects with adverse events
时间窗: 1 week
AUC (area under the concentration-time curve)
时间窗: 1 week
次要结局
未报告次要终点