NCT02922426已完成1 期
A Randomized, Double-Blind, Parallel-Group Study in Healthy Subjects to Characterize Insulin Sensitivity and Lipid Metabolism in Response to Treatment With ALKS 3831 and Olanzapine
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in blood glucose concentrations
研究概览
简要总结
This study will characterize insulin sensitivity in response to treatment with ALKS 3831, olanzapine, and placebo.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) between 18.0 and < 25.0 kg/m^2 at screening and randomization
- •No prior history of regular smoking or nicotine use
- •Women of child-bearing potential should be on stable regimens of oral contraceptives for at least 2 months prior to screening
- •Subjects must be willing to avoid a regular exercise regimen from screening through the end of the treatment period
- •Additional criteria may apply
排除标准
- •Has current evidence or history of any clinically significant medical or psychiatric condition or observed abnormality
- •Is currently pregnant or breastfeeding, or is planning to become pregnant during the study
- •Has a lifetime history of diabetes
- •Has a known risk of narrow-angle glaucoma
- •Has a clinically significant illness within 30 days prior to screening or admission to the clinic
- •Has a history of dependence on any substance other than caffeine
- •Has a current or anticipated need for prescribed opioid medication (eg, planned surgery) during the study period
- •Has a positive urine drug screen for drugs of abuse at screening or admission to the study site
- •Has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to screening or admission to the clinic
- •Has had any vaccinations in the 4 weeks prior to screening or admission to the clinic
- •Chronic use of non-steroid anti-inflammatory drugs (NSAIDs) and acetaminophen, except for low-dose Aspirin is not allowed
- •Use of new prescription and non-prescription drugs, as well as dietary/nutritional supplements within 3 weeks preceding the first dosing of study drugs, unless approved by Investigator
- •Has prior use of any antipsychotic medication, including on and off label uses
- •Additional criteria may apply
研究组 & 干预措施
ALKS 3831
Experimental
Oral, bilayer tablet
干预措施: ALKS 3831 (Drug)
Olanzapine
Active Comparator
Oral, bilayer tablet
干预措施: Olanzapine (Drug)
Placebo
Placebo Comparator
Oral, bilayer tablet
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in blood glucose concentrations
时间窗: 21 days
Differences will be compared among treatment groups
次要结局
- Incidence of treatment-emergent adverse events (AEs)(24 days)
- Changes in insulin concentrations(21 days)
研究者
研究点 (1)
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