NCT01394055已完成1 期
Official Title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single Dose, 2-Period Crossover Study to Evaluate the Pharmacodynamics of RM-131 Administered to Patients With Diabetic Gastroparesis
Motus Therapeutics, Inc.1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年7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
- 20
- 试验地点
- 1
- 主要终点
- Pharmacodynamic (PD) effects of RM-131 on gastric emptying
研究概览
简要总结
The purpose of this study is to evaluate the pharmacodynamic (PD) and pharmacokinetic (PK) profile and the safety and tolerability of RM-131 in patients with diabetes mellitus and delayed gastric emptying.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent prior to any study procedures.
- •Diagnosis of Type 1 or 2 diabetic gastroparesis.
- •Controlled Type 1 or 2 diabetes mellitus (HbA1c <10.1%).
- •Stable concomitant medications defined as no changes in regimen for at least 2 weeks prior to Period 1 (daily adjustments of insulin doses are permitted).
- •Body mass index of 18-40 kg/m².
排除标准
- •Unable or unwilling to provide informed consent or to comply with study procedures.
- •History of gastric surgery such as fundoplication, gastrectomy, gastric pacemaker placement, vagotomy, bariatric procedure. (Note: history of diagnostic endoscopy is not exclusionary).
- •Acute or chronic illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the patient or obscure interpretation of laboratory test results or interpretation of study data such as frequent angina, Class III or IV congestive heart failure, poor renal or hepatic function, etc.
- •Any clinically significant abnormalities on screening laboratories as determined by the Investigator.
- •Abnormal 12-lead electrocardiogram (ECG), including evidence of acute myocardial or subendocardial ischemia and clinically significant arrhythmias or conduction abnormalities or blood pressure at screening except minor deviations deemed to be of no clinical significance by the Investigator.
- •Poor venous access or inability to tolerate venipuncture.
- •Acute GI illness within 48 hours of Period
- •Positive pregnancy test.
- •Participation in a clinical 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
RM-131
Active Comparator
干预措施: RM-131 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pharmacodynamic (PD) effects of RM-131 on gastric emptying
时间窗: Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 1 and Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 2
Change from baseline in gastric half-emptying time by scintigraphy (solids and liquids)
次要结局
- Safety and tolerability of RM-131(Day 1 and 2 after dosing in Period 1 and Day 1 and 2 after dosing in Period 2)
- Pharmacokinetics (PK) of RM-131(Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 1 and Day 1 at baseline vs Day 1 at 6 hours after dosing in Period 2)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
A Study to Assess Pharmacokinetic, Pharmacodynamic, Safety and Tolerability of ASKP1240 in de Novo Kidney TransplantationKidney TransplantationNCT01279538Astellas Pharma Inc50
已完成
1 期
A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia PatientsGout and Asymptomatic HyperuricemiaNCT02317861AstraZeneca110
撤回
1 期
Phase 1 Dexlansoprazole Delayed-Release Capsules for Acid-Related Disorders in Infants Aged 1 to 11 MonthsPediatric Gastroesophageal Reflux DiseaseNCT02442752Takeda
已完成
1 期
Study Comparing Pharmacokinetics of Different Formulations of Evobrutinib in Healthy ParticipantsHealthyNCT05245396Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany58
已完成
2 期
Peginesatide for Anemia in Chronic Hemodialysis PatientsChronic Kidney DiseaseAnemiaChronic Renal FailureNCT00228449Affymax165