Effect of Olorinab on Gastrointestinal Transit in Patients With Irritable Bowel Syndrome
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Gastric emptying half-life (t½) as determined by scintigraphic imaging of radiolabeled meal
研究概览
简要总结
A Phase 1b study to determine the effect of oral olorinab on gastrointestinal transit in adult participants with irritable bowel syndrome (IBS).
详细描述
This is a single-center, randomized, crossover, double-blind, placebo-controlled study designed to evaluate the effects of olorinab on gastric, small-bowel, and colonic transit in IBS participants with predominant constipation (IBS-C) or with predominant diarrhea (IBS-D).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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
- •Diagnosis of irritable bowel syndrome (IBS) with predominant constipation (IBS-C) or IBS with predominant diarrhea (IBS-D) according to Rome IV criteria at Screening
- •Body mass index (BMI) 18.0 to 40.0 kilograms per square meter (kg/m^2), inclusive at Screening
- •Negative test results for alcohol and selected drugs at Screening and Day 1
- •Negative hepatitis panel (including hepatitis B surface antigen [HBsAg] and hepatitis C virus antibody [anti-HCV]) and negative for human immunodeficiency virus (HIV) antibody screens at Screening
- •Participants with recent (within 6 months of Screening) or ongoing alarm features (unexplained weight loss, nocturnal symptoms, blood mixed with stool) are to have had a diagnostic colonoscopy prior to Screening and after the onset of alarm features (for participants with alarm features) to exclude non-IBS conditions per the Rome IV diagnostic algorithm for IBS
排除标准
- •Pregnant or lactating
- •Structural or metabolic diseases/conditions that affect the gastrointestinal system
- •Diagnosis of IBS with mixed bowel habits (IBS-M) or unsubtyped IBS (IBS-U)
- •Unable to withdraw medications that alter gastrointestinal (GI) transit for 72 hours prior to baseline colonic transit assay through the duration of treatment period, with the exception of rescue medicine usage (bisacodyl and loperamide)
- •Clinically relevant changes in dietary, lifestyle, or exercise regimen within 30 days prior to Screening and for the duration of the study that may confound efficacy assessments in the clinical judgment of the Investigator (or designee)
研究组 & 干预措施
Olorinab, Then Placebo
Participants will first receive olorinab, followed by a washout period, and they then will receive placebo.
干预措施: Olorinab (Drug)
Olorinab, Then Placebo
Participants will first receive olorinab, followed by a washout period, and they then will receive placebo.
干预措施: Placebo (Drug)
Placebo, Then Olorinab
Participants will first receive placebo, followed by a washout period, and they then will receive olorinab.
干预措施: Olorinab (Drug)
Placebo, Then Olorinab
Participants will first receive placebo, followed by a washout period, and they then will receive olorinab.
干预措施: Placebo (Drug)
结局指标
主要结局
Gastric emptying half-life (t½) as determined by scintigraphic imaging of radiolabeled meal
时间窗: up to 4 hours 10 minutes after consumption of radiolabeled meal
Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule
时间窗: up to 24 hours 30 minutes after consumption of radiolabeled meal
次要结局
- Gastric emptying after radiolabeled meal(at 2 hours ± 10 minutes and 4 hours ± 10 minutes after consumption of radiolabeled meal)
- Number and severity of adverse events(Up to approximately 6 weeks)
- Colonic transit geometric center after consumption of radiolabeled meal, based on the delivery of activated charcoal in a methacrylate-coated capsule(up to 48 hours 30 minutes after consumption of radiolabeled meal)
- Ascending colon emptying t½ of radiolabeled activated charcoal particles delivered in a methacrylate-coated capsule(up to 24 hours 30 minutes after consumption of radiolabeled meal)