NCT00859755已完成1 期
A Safety Study of ARRY-403 in Patients With Type 2 Diabetes
Array BioPharma1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
研究概览
简要总结
This is a Phase 1 study, involving a 1-day dosing period, designed to test the safety of investigational study drug ARRY-403 in patients with Type 2 diabetes. Approximately 36 patients from the US will be enrolled in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female with willingness and ability to use protocol-specified methods of contraception, except females of nonchildbearing potential.
- •Diagnosis of Type 2 diabetes less than 5 years prior to study start.
- •HbA1c ≥ 6.5% and ≤ 10%.
- •BMI ≥ 25 and ≤ 40.0 kg/m
- •Additional criteria exist.
排除标准
- •Recent history (i.e., less than 6 months) or concomitant/ongoing clinically significant hematologic, renal, pulmonary, gastrointestinal, hepatic, psychiatric, neurologic, dermatologic, or allergic disease (including drug allergies that are clinically significant and not remote, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
- •Significant cardiac disease, myocardial infarction within 6 months of study start, unstable angina, congestive heart failure, known arrhythmias of ventricular etiology, unexplained syncope or syncope/seizures related to arrhythmia.
- •History of gastric surgery, vagotomy, bowel resection, or any surgical procedure that might interfere with gastrointestinal motility, pH, or absorption.
- •Active infectious diseases including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV). Past history and inactive hepatitis B and C, as confirmed by serological testing, are allowed.
- •A positive test for drugs or alcohol.
- •Women who are pregnant or breastfeeding.
- •Donation or loss of ≥ 550 mL of blood (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to first dose of study drug.
- •Additional criteria exist.
研究组 & 干预措施
ARRY-403
Experimental
干预措施: ARRY-403, glucokinase activator; oral (Drug)
Placebo
Placebo Comparator
干预措施: Placebo; oral (Drug)
结局指标
主要结局
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
时间窗: Duration of study
Characterize the pharmacokinetics (PK) of the study drug and metabolites in terms of plasma concentrations.
时间窗: Day 1, Day 2
次要结局
- Characterize the pharmacodynamic (PD) activity of the study drug on biomarkers.(Day 1, Day 2)
- Assess the ability of the study drug to improve glucose tolerance as determined by blood glucose monitoring during a standardized meal challenge.(Day 1, Day 2)
- Assess the excretion of the study drug and metabolites in urine following dosing.(Day 1, Day 2)
研究者
研究点 (1)
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