NCT02466711已完成1 期
A Single-center, Placebo-controlled, Double-blind Study to Evaluate the Effect of Relamorelin on Satiation, Gastric Volume, Gastric Accommodation and Distal Gastric Function in Healthy Volunteers
Motus Therapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2015年6月最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Gastric volume measured by single photon emission computed tomography (SPECT)
研究概览
简要总结
The purpose of this study is to evaluate the effects of relamorelin (RM-131) on gastric volume, motor and sensory effects in healthy patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- 是
入选标准
- •Able to provide written informed consent prior to any study procedures, and be willing and able to comply with study procedures
- •No medical problems or chronic diseases, specifically, no type 2 diabetes mellitus
- •Body mass index of 18-35 kg/m²
- •Female subjects must have negative urine pregnancy tests and must not be lactating prior to receiving study medication and radiation exposure. For females able to bear children, a hormonal (i.e., oral, implantable, or injectable) and single-barrier method, or a double-barrier method of birth control must be used throughout the study. Female subjects unable to bear children must have this documented in the medical record (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
排除标准
- •Unable or unwilling to provide informed consent or to comply with study procedures
- •Diagnosis of gastrointestinal diseases
- •Structural or metabolic diseases that affect the GI system
- •Unable to avoid the following over- the- counter medications 48 hours prior to the baseline period and throughout the study:
- •Medications that alter GI transit including laxatives, magnesium and aluminum containing antacids, prokinetics, erythromycin,
- •Analgesic drugs including NSAIDs and COX-2 inhibitors NOTE: stable doses of thyroid replacement, estrogen replacement, low-dose aspirin for cardioprotection, and birth control (but with adequate backup contraception as drug-interactions with birth control have not been conducted) are permissible.
- •History of recent surgery (within 60 days of screening)
- •Acute or chronic illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the subject or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, moderate impairment of renal or hepatic function, poorly controlled diabetes, etc.
- •Any clinically significant abnormalities on physical examination or laboratory abnormalities identified in the medical record, as determined by the Investigator
- •Acute GI illness within 48 hours of initiation of the baseline period
- •Females who are pregnant or breastfeeding
- •History of excessive alcohol use or substance abuse
- •Participation in an investigational study within the 30 days prior to dosing in the present study
- •Any other reason, which in the opinion of the Investigator, would confound proper interpretation of the study
研究组 & 干预措施
Relamorelin
Active Comparator
干预措施: Relamorelin (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Gastric volume measured by single photon emission computed tomography (SPECT)
时间窗: Measured during the 1 hour study procedure
Calculation of gastric volume by single photon emission computed tomography (SPECT)
Satiety measured by the Hunger/Satiety questionnaire
时间窗: Measured during a 1 hour study procedure
Measurement of satiety by completion of the Hunger/Satiety questionnaire after ingesting a nutrient drink
Gastric motility measured by gastroduodenal manometry
时间窗: Measured during the 4 hour study procedure
Measurement of gastric motility by gastroduodenal manometry
次要结局
未报告次要终点
研究者
研究点 (1)
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