Study Evaluating the Effect of TC-6499 on Gastric Emptying Time in Diabetic Subjects With Gastroparesis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 8
- 主要终点
- The change in gastric emptying half-time determined for each treatment relative to placebo after single dose administration of study drug in each arm.
研究概览
简要总结
Gastroparesis, also referred to as delayed gastric emptying, is a debilitating, chronic disorder that slows or stops the passage of food from the stomach to the small intestine. The purpose of this study is to test whether TC-6499 is safe and effective at reducing gastric emptying time in diabetic subjects with gastroparesis.
详细描述
This is a 4-way crossover study to assess the effect of TC-6499 on gastric emptying time in diabetic subjects with gastroparesis. The length of study participation for a subject is up to 50 days. During screening, eligible subjects will complete an oral 13-C-spirulina breath test also known as the Gastric Emptying Breath Test (GEBT). During the treatment period, subjects will complete 4 overnight drug assessment visits (treatment arms) where they will receive a randomized single dose of study drug and the GEBT. Each overnight visit will be separated by approximately 7 days. At least 18 subjects will be randomized and complete all 4 dosing arms (actual = 23 randomized subjects and 21 completing all 4 arms of the crossover).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of gastroparesis or symptoms consistent with gastroparesis for at least 6 months (and Gastroparesis Cardinal Symptoms Index total score >22)
- •Gastroparesis confirmed using the GEBT
- •Type 1 or Type 2 diabetes with a Hemoglobin A1c ≤ 10%
- •Fasting blood glucose (finger stick) ≤ 275 mg/dL prior to each GEBT
- •Body Mass Index (BMI) ≤ 40
- •Willingness to remain in clinical research facility for the protocol-required days of treatment and study procedures
- •Willingness to use a double barrier method of birth control (except post-menopausal females)
- •Able to understand study procedures and provide written informed consent
排除标准
- •History of abdominal surgery including gastric banding procedure
- •Chronic parenteral feeding or feeding through a gastrostomy or jejunostomy tube
- •Persistent daily vomiting
- •A history of eating disorder
- •Recent history of poor control of diabetes
- •Acute severe gastroenteritis
- •Have implanted or use any type of gastric electric stimulator
- •Use of opiates, anticholinergic medications, GLP-1 mimetics or amylin analogs
- •Use of medications potentially influencing upper gastrointestinal motility or appetite
- •Allergies or intolerance to egg, wheat, milk, or algae
- •Pregnant or lactating females
- •Presence of a clinically significant medical condition at any time during the study
- •Presence of clinically significant abnormalities in laboratory findings, physical exam findings or vital signs
- •Participated in an investigational drug study within 30 days of screening
研究组 & 干预措施
5 mg TC-6499
One capsule of 5 mg TC-6499 administered as a single dose.
干预措施: TC-6499 (Drug)
Placebo
One capsule of placebo administered as a single dose.
干预措施: Placebo (Drug)
2 mg TC-6499
One capsule of 2 mg TC-6499 administered as a single dose.
干预措施: TC-6499 (Drug)
10 mg TC-6499
One capsule of 10 mg TC-6499 administered as a single dose.
干预措施: TC-6499 (Drug)
结局指标
主要结局
The change in gastric emptying half-time determined for each treatment relative to placebo after single dose administration of study drug in each arm.
时间窗: 4 hrs post-GEBT meal
Gastric emptying time will be assessed using the oral 13-C-spirulina breath test also known as the Gastric Emptying Breath Test (GEBT) administered following each treatment.
次要结局
- The percent dose excreted as 13-CO2 at specific post-meal time points for each treatment relative to placebo after single dose administration of study drug in each arm.(90 and 120 min post-GEBT meal)
- The time of maximal rate of 13-CO2 expiration for each treatment relative to placebo after single dose administration of study drug in each arm.(4 hrs post-GEBT meal)