A Phase 1, Randomized, Placebo-Controlled, Parallel Group, 14 Day Repeated Dose Escalation Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04971729 In Otherwise Healthy Overweight And Obese Adult Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Trough concentration of serum intact parathyroid hormone (Ctrough)
研究概览
简要总结
Ertugliflozin (PF-04971729, MK-8835) is under development for the treatment of Type 2 Diabetes. The primary purpose of this trial is to evaluate the safety and tolerability, pharmacokinetics and pharmacodynamics, of multiple oral doses of ertugliflozin.
详细描述
To evaluate the safety and tolerability, pharmacokinetics (PK), and pharmacodynamics, of multiple oral doses of ertugliflozin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
- •Body Mass Index (BMI) of 26.5 to 35.5 kg/m2; and a total body weight >50 kg (110 lbs).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- •Evidence of glycosuria, as defined by a positive urine dipstick test; Fasting (at least 10 hours) serum triglyceride >300 mg/dL; Fasting (at least 10 hours) LDL-cholesterol >190 mg/dL; Fasting (at least 10 hours) serum 25-OH Vitamin D concentration <20 ng/mL
研究组 & 干预措施
Ertugliflozin up to 100 mg
Ertugliflozin up to 100 mg, once daily for 14 days
干预措施: Ertugliflozin (Drug)
Ertugliflozin 1 mg
Ertugliflozin 1 mg, oral, once daily for 14 days
干预措施: Ertugliflozin (Drug)
Ertugliflozin up to 5 mg
Ertugliflozin up to 5 mg, oral, once daily for 14 days
干预措施: Ertugliflozin (Drug)
Ertugliflozin up to 25 mg
Ertugliflozin up to 25 mg, oral, once daily for 14 days
干预措施: Ertugliflozin (Drug)
Placebo
Placebo to Ertugliflozin once daily for 14 days
干预措施: Placebo to Ertugliflozin (Drug)
结局指标
主要结局
Trough concentration of serum intact parathyroid hormone (Ctrough)
时间窗: Up to 17 days
Area under the plasma concentration-time curve over 8 hours (AUC[0-8]) for serum intact parathyroid hormone
时间窗: Up to 17 days
Change from baseline in 24-hour urinary glucose excretion
时间窗: Baseline and Day 14
Change from baseline in 24-hour plasma C-peptide
时间窗: Baseline and Day 14
Area under the plasma concentration-time curve over 24 hours (AUC[0-24]) for serum intact parathyroid hormone
时间窗: Up to 17 days
Number of Participants Discontinuing Study Drug Due to an AE
时间窗: Up to 14 days
Maximum plasma concentration (Cmax) of ertugliflozin
时间窗: Up to 17 days
Ertugliflozin half life (t1/2)
时间窗: Up to 17 Days
Observed Accumulation Ratio of Area Under the Curve for the dosing interval of ertugliflozin (Rac[obs])
时间窗: Up to 17 days
Area under the plasma concentration-time curve (AUC) over the dosing interval tau (AUCtau) for ertugliflozin
时间窗: Up to 17 days
Time taken to reach the maximum observed plasma concentration (Tmax) of ertugliflozin
时间窗: Up to 17 days
Change from baseline in 24-hour weighted mean glucose
时间窗: Baseline and Day 14
Change from baseline in body weight
时间窗: Baseline and Day 14
Apparent clearance (CL/F) after a single dose of ertugliflozin
时间窗: Up to 17 days
Apparent volume of distribution (Vz/F)
时间窗: Up to 17 days
Inhibition of glucose reabsorption
时间窗: Baseline and Day 14
Number of Participants Experiencing an Adverse Event (AE)
时间窗: Up to 28 days postdose (Up to 42 days)
次要结局
未报告次要终点