临床试验/NCT01223339

NCT01223339已完成1 期

A Phase 1, Randomized, Double Blind, Placebo-Controlled, Parallel Cohort, Single Dose Escalation And Multiple Dose Study In Japanese Healthy Subjects, And Open Label, Single Dose Escalation Study In Western Healthy Subjects To Investigate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PF-04971729

Merck Sharp & Dohme LLC0 个研究点目标入组 24 人开始时间: 2010年10月最近更新: 2016年5月20日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 24
主要终点: AUClast for ertugliflozin for the Multiple Dose Cohort

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is to characterize the pharmacokinetics, safety, tolerability, and pharmacodynamics of single and multiple oral doses (SD, MD) of ertugliflozin (PF-04971729, MK-8835) in Japanese healthy participants. The secondary objective is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of ertugliflozin in Western healthy participants as compared to Japanese healthy participants.

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: 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 of non-childbearing potential, between the ages of 18 and 55 years, inclusive
•Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
•Japanese subjects must have four Japanese grandparents who were born in Japan.
•Mean body weight and the body weight range of Western subjects are similar to those of Japanese subjects with a 10% plus and minus error.
•An informed consent document signed and dated by the subject.
•Subjects who are willing and able to comply with scheduled visits, treatment plan,laboratory tests, and other study procedures.

排除标准

•Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease
•Asian or Polynesian subjects in Western subject groups.
•Any condition possibly affecting drug absorption (eg, gastrectomy).
•A positive urine drug screen.
•History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for males within 6 months of screening.
•History or evidence of habitual use of tobacco or nicotine containing products within 3 months of Screening, with the exception of light smoking (up to 5 cigarettes per day or the equivalent).
•Treatment with an investigational drug within 30 days or 5 half-lives preceding the first dose of study medication.
•12-lead ECG demonstrating QTc >450 msec at screening.
•Subjects with ANY of the following abnormalities on safety laboratory tests):
•Evidence of glycosuria, as defined by a positive urine dipstick test;
•Fasting serum triglyceride >300 mg/dL;
•Fasting LDL-cholesterol > than or equal to 190 mg/dL.
•Fasting serum glucose >125 mg/dL.

研究组 & 干预措施

Single Dose Japanese Cohort

Experimental

This will be a single dose Cohort in which Japanese healthy participants will receive 3 ascending single doses (1 mg, 5 mg, and 25 mg) of ertugliflozin or placebo through 3 dosing periods. A minimum wash out period of 7-days will be set between each dose administration.

干预措施: Ertugliflozin (Drug)

Single Dose Japanese Cohort

Experimental

干预措施: Placebo (Drug)

Single dose Western cohort

Experimental

This will be a single dose Cohort in which Western healthy participants will receive 3 ascending single doses (1 mg, 5 mg, and 25 mg) of ertugliflozin through 3 dosing periods. A minimum wash out period of 7-days will be set between each dose administration.

干预措施: Ertugliflozin (Drug)

Multiple Dose Japanese Cohort

Experimental

This will be a multiple dose Cohort in which Japanese healthy participants will receive once-daily 25 mg ertugliflozin or placebo for 7 days.

干预措施: Ertugliflozin (Drug)

Multiple Dose Japanese Cohort

Experimental

This will be a multiple dose Cohort in which Japanese healthy participants will receive once-daily 25 mg ertugliflozin or placebo for 7 days.

干预措施: Placebo (Drug)

结局指标

主要结局

AUClast for ertugliflozin for the Multiple Dose Cohort

时间窗: Up to Day 10

AUCinf for ertugliflozin for the Multiple Dose Cohort

时间窗: Up to Day 10

t1/2 for the Multiple Dose Cohort

时间窗: Up to Day 10

CL/F of ertugliflozin for the Multiple Dose Cohort

时间窗: Up to Day 10

Vz/F for the Multiple Dose Cohort

时间窗: Up to Day 10

Urinary Glucose Excretion over 24 hours for the Single Dose Cohort

时间窗: Up to 24 hours postdose (Up to Day 2)

Cmax of ertugliflozin for the Multiple Dose Cohort

时间窗: Up to Day 10

Tmax of ertugliflozin for the Multiple Dose Cohort

时间窗: Up to Day 10

Maximum plasma concentration (Cmax) of ertugliflozin for the Single Dose Cohort