JPRN-UMIN000012713已完成1 期
A Phase I, Placebo-Controlled, Dose-Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EGT0001442 In Healthy Japanese Volunteers and Subjects with Type 2 Diabetes Mellitus - A Phase I study for EGT0001442 in Healthy Japanese Volunteers and Subjects with Type 2 Diabetes Mellitus
Integrated development Associates Co., Ltd(CTICC) Theracos Inc.(Sponsor)0 个研究点目标入组 62 人开始时间: 2013年12月27日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
研究概览
简要总结
The PK and PD parameters for EGT0001442 are similar between American and Japanese populations. Administration of EGT0001442 to Japanese subjects was safe and well tolerated. Prior consumption of food was not found to markedly change the PK parameters observed following administration of the 10 and 30 mg dosage forms. EGT0001442 reduced fasting plasma glucose in Japanese volunteers with T2DM. The results of this study provide justification for the further clinical development of EGT0001442 in Japan.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 70years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •Part 1 1.Subjects who are determined by the investigator or sub-investigator to be unsuitable for participating in the study based on medical conditions, including impairment of the central nervous system, circulatory system, respiratory system, blood/hematopoietic function system, gastrointestinal system, liver/kidney function, thyroid function, pituitary function and/or adrenal function 2.Subjects with a history of allergy to drugs or latex 3.Subjects with a history of alcohol or drug dependence 4.Subjects with a history of bladder dysfunction, such as incontinence, pollakiuria, or nocturia etc. Part 2 1.Subjects treated with anti-diabetic medication at any time within the 12 weeks prior to screening 2.Subjects having any major health problems other than type 2 diabetes, such as stroke or myocardial infarction or any conditions that required cardiac or peripheral re-vascularization procedures within the 6 months prior to screening 3.Female subjects who are pregnant, lactating, or who showed positive results in urine pregnancy test at screening etc.
研究者
相似试验
已完成
1 期
Phase 1, Single Dose Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of MEDI5884Healthy VolunteersNCT03001297MedImmune LLC64
已完成
1 期
Phase 1 Study to Evaluate the PK, Safety, Tolerability of BIIB023 in Chinese, Japanese, and Caucasian Healthy VolunteersHealthy VolunteersNCT01407406Biogen48
已完成
1 期
A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein CholesterolHyperlipidemiaNCT01426412Eli Lilly and Company69
已完成
2 期
An add-on Study of E2007 in Patients With Refractory Partial Seizures Uncontrolled With Other Anti-epileptic Drugs (AEDs)Refractory Partial SeizuresNCT00849212Eisai Co., Ltd.30
已完成
1 期
Study in Japan and Ex-Japan to Characterize the Pharmacokinetic and Pharmacodynamic Response to Orteronel (TAK-700) in Chemotherapy-Naive Participants With Castration-Resistant Prostate CancerProstate CancerNCT01666314Millennium Pharmaceuticals, Inc.137