A Phase 1, Randomized, Double-Blind, Placebo-Controlled, 4-Period, Crossover Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Three Dose Levels of the Investigational Drug (PB-201) in Drug-naive Adult Subjects With Type 2 Diabetes Mellitus as Monotherapy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Time to peak(Tmax)
研究概览
简要总结
This crossover study investigates the safety, tolerability, pharmacokinetics (PK) ,pharmacodynamics (PD) effect of three dose levels of PB-201,and characterizes the PK profile of a prominent des-methyl metabolite of PB-201(WI-0800), following dosing of three dose levels of PB-201 in drug-naive Chinese adult subjects with Type 2 diabetes mellitus (T2DM) as monotherapy.
There were 7 days separating 4 treatment periods and at least 7-day washout (but not exceeding 14 days) between dosing in 4 periods with 3 dose levels of PB-201 and placebo. Three dose levels of PB-201 are: split dose regimen of 50 mg 30 minutes before morning meal plus 50 mg 30 minutes before lunch at approximately 3.5 hours after morning dose, and split dose regimen of 100 mg 30 minutes before morning meal plus 100 mg 30 minutes before lunch at approximately 3.5 hours after morning dose, and split dose regimen of 150 mg 30 minutes before morning meal plus 100 mg 30 minutes before lunch at approximately 3.5 hours after morning dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glycosylated hemoglobin (HbA1c) 7.5%-11% at screening, and 7.0%-10.0% pre-randomization
- •FPG 7.0 mmol/L-11.0mmol/L at screening and pre-randomization
- •Body mass index (BMI) 18.5 and-35.0 kg/m2 at screening
- •Antidiabetics-naive within 2 months before screening
排除标准
- •Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes
- •History of febrile illness within 5 days prior to dosing
- •Medical history of myocardial infarction, angina/unstable angina, coronary revascularization, stroke or transient ischemic attack
- •Any medical history or current clinical evidence of congestive heart failure, New York Heart Association (NYHA) Functional Classification, Classes II-IV
- •Episode(s) of hypoglycemia adverse events (HAE) of 'severe' intensity prior to screening; either:
- •>1 in the previous 3 months; or
- •>2 in the previous 6 months
研究组 & 干预措施
PB-201 50/50mg by mouth,every morning and noon for 7 days
干预措施: glucokinase activator (Drug)
PB-201 100/50mg by mouth,every morning and noon for 7 days
干预措施: glucokinase activator (Drug)
PB-201 100/100mg by mouth,every morning and noon for 7 days
干预措施: glucokinase activator (Drug)
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Time to peak(Tmax)
时间窗: 9 days
hour
Peak Plasma Concentration (Cmax)
时间窗: 9 days
ng/mL
Area under the plasma concentration versus time curve (AUC)
时间窗: 9 days
ng•hr/mL
次要结局
- The change for plasma insulin(8 days)
- The change for fasting plasma glucose (FPG)(8days)
- The change for postprandial plasma glucose (PPG)(8 days)
- The change for plasma C-peptide(8 days)