NCT01492465终止1 期
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 876 in Subjects With Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Subject incidence of treatment-emergent adverse events
研究概览
简要总结
The purpose of this study is to determine whether AMG 876 is safe and well tolerated in subjects with type 2 diabetes.
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
- 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
- •Subject has provided written informed consent
- •Men and women between the ages of 18 and 65, inclusive at the time of randomization
- •Women must be of documented non-reproductive potential (ie, postmenopausal [see definition below]; OR history of hysterectomy; OR history of bilateral tubal ligation; OR history of bilateral oophorectomy).
- •Diagnosed with type 2 diabetes
- •HbA1c ≥ 6.5% and ≤ 10%
- •Fasting C-peptide value ≥ 0.8 ng/mL
- •Men must agree for the duration of the study and continuing for 4 weeks after the dose of study drug, to practice a highly effective method of birth control. Highly effective methods of birth control include sexual abstinence, vasectomy or a condom with spermicide (men) in combination with either barrier methods, hormonal birth control or IUD (women).
- •Men must agree to not donate sperm for the duration of the study and continuing for 4 weeks after the dose of study drug.
- •Body mass index between ≥ 25.0 kg/m2 and ≤ 40.0 kg/m2 at screening
- •Negative screening test for alcohol and potential drugs of abuse at screening and day -2, unless medication is prescribed by a physician and approved by the principal investigator and Amgen medical monitor
排除标准
- •Men with partners who are pregnant at the time of screening or men with partners who plan to become pregnant during the study
- •Women who are pregnant or breastfeeding History or evidence of a clinically significant disorder, condition or disease that, in the opinion of the principal investigator or Amgen medical monitor would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
- •Evidence or history at screening of diabetic complications with significant end-organ damage, eg, proliferative retinopathy and/or macular edema, creatinine clearance < 60 mL/min/1.73m2 (calculated using the Modification of Diet in Renal Disease formula), or macroalbuminuria (ie, ≥ +1 proteinuria on urinalysis), diabetic neuropathy complicated by neuropathic ulcers, or severe autonomic neuropathy with gastroparesis, chronic diarrhea, or hypoglycemic unawareness
- •Significant cardiac disease, including but not limited to evidence or history of coronary artery disease, unstable angina, congestive heart failure, known arrhythmias of ventricular etiology, unexplained syncope or syncope/seizures related to arrhythmia
- •Positive for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (Hbs Ag), or hepatitis C virus antibodies
- •An unstable medical condition, defined as having been hospitalized within 28 days before day -1, major surgery within 6 months before day -1, or otherwise unstable in the judgment of the investigator (eg, risk of complications or adverse events unrelated to study participation)
研究组 & 干预措施
AMG 876
Active Comparator
干预措施: AMG 876 (Drug)
Placebo
Placebo Comparator
干预措施: AMG 876 (Drug)
结局指标
主要结局
Subject incidence of treatment-emergent adverse events
时间窗: 29 days
Physical examinations, vitals, clinical laboratories, and ECGs
Safety laboratory analytes, vital signs, and ECGs
时间窗: 29 days
laboratory analytes, vital signs, and ECGs
Subject incidence of anti-AMG 876 antibodies.
时间窗: 29 days
laboratories analytes
次要结局
- AMG 876 serum PK parameters(29 days)
- Pharmacodynamic parameters:(29 days)
研究者
研究点 (1)
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