A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Dose Response of Oral CIN-102 in Adults With Idiopathic and Diabetic Gastroparesis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 19
- 主要终点
- Change from baseline in gastric emptying
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled Phase 2A study to evaluate safety, efficacy, PK, and dose response of oral CIN-102 in adults with idiopathic and diabetic gastroparesis. The study will assess three oral doses of CIN-102 versus placebo in three separate cohorts.
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.
- •Current diagnosis of idiopathic or diabetic gastroparesis OR documented delayed gastric emptying.
- •Presence of moderate to severe nausea.
- •Body mass index (BMI) between 18 and 40 kg/m2, inclusive.
- •Glycosylated hemoglobin level <11% at Screening.
- •Willing to washout from ongoing treatment for gastroparesis.
- •Able to understand and willing to comply with all study visits, procedures, restrictions, and provide written informed consent according to institutional and regulatory guidelines.
排除标准
- •Other known disorder or treatment which could explain or contribute to symptoms of gastroparesis.
- •Positive test for drugs of abuse at the screening or evaluation visits.
- •Personal or family history of prolonged heart rate-corrected QT.
- •History or evidence of clinically significant arrhythmia.
- •History of gastrectomy, fundoplication, vagotomy, pyloroplasty, or bariatric surgery.
- •Females who are pregnant, nursing, or planning on becoming pregnant during the study.
研究组 & 干预措施
Cohort 1
CIN-102 tablets by mouth twice daily for 14 days
干预措施: CIN-102 Dose 1 (Drug)
Cohort 1 - Placebo
Placebo tablets by mouth twice daily for 14 days
干预措施: Placebo (Drug)
Cohort 2
CIN-102 tablets by mouth twice daily for 14 days
干预措施: CIN-102 Dose 2 (Drug)
Cohort 2- Placebo
Placebo tablets by mouth twice daily for 14 days
干预措施: Placebo (Drug)
Cohort 3
CIN-102 tablets by mouth twice daily for 14 days
干预措施: CIN-102 Dose 3 (Drug)
Cohort 3- Placebo
Placebo tablets by mouth twice daily for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in gastric emptying
时间窗: Baseline (gathered on Days -10 to -3) to Day 14
次要结局
- The change from baseline in ANMS GCSI-DD subscale scores(Day -14 to 14)
- Change from baseline in gastric emptying terminal phase elimination half life(Baseline (gathered on Days -10 to -3) to Day 14)
- The change from baseline in ANMS GCSI-DD total scores(Day -14 to 14)