NCT04208698终止2 期
A Randomized, Double-Blind Placebo-Controlled Scintigraphy Study to Investigate the Effect of CIN-102 on Gastric Emptying and Antral Contractility in Adults With Diabetic Gastroparesis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- To Evaluate the Change From Baseline in Gastric Percentage Retention of a Radiolabeled Meal After Dosing CIN-102 in Patients With Diabetic Gastroparesis.
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled scintigraphy study to investigate the effect of oral CIN-102 on gastric emptying and antral contractility in adults with diabetic gastroparesis.
详细描述
This is a randomized, double-blind, placebo-controlled scintigraphy study to investigate the effect of oral CIN-102 on gastric emptying and antral contractility in adults with diabetic gastroparesis. The population for this study is adult patients 18 to 70 years old with Type 1 or Type 2 diabetes and a diagnosis of diabetic gastroparesis. The study will consist of two cohorts with approximately 15 subjects in each cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, 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
- •Male and female patients 18 to 70 years old, inclusive.
- •Type 1 or Type 2 diabetes mellitus, according to American Diabetes Association criteria
- •Current diagnosis of diabetic gastroparesis.
- •Body Mass Index (BMI) between 18 and 40 kg/m2, inclusive.
- •Glycosylated hemoglobin level <11% at Screening.
- •Willing to abstain from tobacco or nicotine-containing product use after midnight on the day of the DAS test and throughout the time that gastric emptying is being imaged.
- •Willing to abstain from grapefruit, grapefruit products, star fruit, star fruit products, and Seville oranges from 72 hours prior to the Randomization Visit until end of study.
排除标准
- •History of, or current, clinically significant arrhythmias as judged by the Investigator, including ventricular tachycardia, ventricular fibrillation, atrial fibrillation, and Torsades de Pointes. Patients with minor forms of ectopy (eg, premature atrial contractions) are not necessarily excluded.
- •Clinically significant bradycardia with a resting heart rate under 50 beats per minute, sinus node dysfunction, or heart block.
- •Prolonged heart rate-corrected QT interval using Fridericia's formula (QTcF) (QTcF >450 msec for males or QTcF >470 msec for females) based on the average of triplicate ECGs.
- •A personal or family history of long QT syndrome, Torsades de pointes, or other complex ventricular arrhythmias or family history of sudden death.
- •Evidence (based on Screening or Baseline assessments) or history of clinically significant immunologic, hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies); surgical conditions; cancer (with the exception of basal or squamous cell carcinoma of the skin and cancer that resolved or has been in remission for >5 years prior to the Screening Visit); or any condition that, in the Investigator's opinion, might significantly interfere with the absorption, distribution, metabolism, or excretion of the study drug.
- •History of prolactin-releasing pituitary tumor (ie, prolactinoma).
- •Allergic to egg or intolerant to gluten.
- •History of alcoholism or drug abuse within 2 years prior to dosing as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition.
- •Known or suspected gastric outlet obstruction (eg, peptic stricture) or other gastrointestinal mechanical obstruction.
- •Known history or current diagnosis of intestinal malabsorption or pancreatic exocrine disease.
- •History or presence of any medical condition or psychiatric disease, which, in the opinion of the Investigator, could interfere with the conduct of the study or would put the patient at unacceptable risk.
- •Judged by the Investigator, after reviewing medical and psychiatric history, physical examination, and laboratory evaluation, to be unsuitable for any other reason that may either place the patient at increased risk during participation or interfere with the interpretation of the study outcomes.
研究组 & 干预措施
CIN-102 Tablets Dose 1
Experimental
CIN-102 tablets by mouth twice daily for 14 days
干预措施: CIN-102 Dose 1 (Drug)
Placebo for CIN-102 Dose 1
Placebo Comparator
Placebo tablets by mouth twice daily for 14 days
干预措施: Placebo for CIN-102 (Drug)
CIN-102 Dose 2
Experimental
CIN-102 tablets by mouth twice daily for 14 days
干预措施: CIN-102 Dose 2 (Drug)
Placebo for CIN-102 Dose 2
Placebo Comparator
Placebo tablets by mouth twice daily for 14 days
干预措施: Placebo for CIN-102 (Drug)
结局指标
主要结局
To Evaluate the Change From Baseline in Gastric Percentage Retention of a Radiolabeled Meal After Dosing CIN-102 in Patients With Diabetic Gastroparesis.
时间窗: Baseline to Day 14
次要结局
- To Evaluate the Incidence of Treatment-emergent Adverse Effects as Measured by Safety Laboratory Data and Patient Reported Events.(Screening to Day 20)
- To Assess the Change in Baseline of the Clinical Grading Assessment Scale(Baseline to Day 14)
- To Assess the Effect of CIN-102 on Gastric Accommodation to be Evaluated Using Data Captured During the Total-stomach Gastric Emptying Study to Measure Food Retention in the Stomach During the First Two Post-prandial Hours.(Baseline to Day 14)
- To Assess the Change From Baseline in ANMS GCSI-DD Subscale Scores(Day -14 to 14)
- To Assess the Effect of CIN-102 on Antral Contractility as Measured by Dynamic Antral Scintigraphy (DAS), a Non-invasive Technique for the Assessment of Post-prandial Gastric Contractions Will be Used to Evaluate Antral Motility.(Baseline to Day 14)
- To Asses the Change From Baseline in ANMS GCSI-DD Total Scores(Day -14 to 14)
- To Assess the Change From Baseline in Symptom Severity as Measured by the PAGI-SYM(Baseline to Day 14)
研究者
研究点 (1)
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