A Phase 1, Single Centre, Open Label, Crossover Study in Healthy Volunteers Using Scintigraphy to Evaluate the Gastrointestinal Behaviour of EDP1815 Oral Dosage Forms.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Time to onset of radiolabel release
研究概览
简要总结
This study is to find out how different types of capsules or tablets containing EDP1815 move through the GI tract and release the drug after being swallowed. The capsules and tablets also contain a very small dose of a commonly used radioactive label called technetium-99m which is released in the GI tract to be seen on pictures taken by a scanner (gamma scintigraphy).
详细描述
This is a Phase I single centre, crossover, gamma scintigraphy study to investigate the gastrointestinal transit and disintegration kinetics of capsule and tablet formulations of EDP1815 (which contains a specific pure strain of Prevotella histicola, a natural human commensal organism).
In Part 1, up to 12 healthy male volunteers will receive single doses of EDP1815 administered either as capsules or tablets in 4 treatment periods.
The data generated in Part 1 will be assessed prior to progressing to Part 2 to select formulations and doses to be studied. Part 2 will include gamma scintigraphy in up to 12 healthy volunteers receiving single doses of EDP1815 capsules over up to 4 treatment periods.
The data generated in Part 2 will be assessed prior to progressing to Part 3 to select formulations and doses to be studied. Part 3 will include gamma scintigraphy in up to 12 healthy volunteers receiving single doses of EDP1815 capsules or tablets over up to 4 treatment periods.
The data generated in Part 3 will be assessed prior to progressing to Part 4 to select formulations and doses to be studied. Part 4 will include gamma scintigraphy in up to 12 healthy volunteers receiving single doses of EDP1815 tablets over up to 4 treatment periods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body weight ≥50 kg and BMI 18-30 kg/m²
排除标准
- •History or presence of any medical condition or abnormal laboratory test findings at screening that could affect the study conduct/results, or make the participant unlikely to fully complete the study or potentially adversely affect their safety due to taking part.
- •History of non-self-limiting gastrointestinal disorders, or currently suffering from disease known to impact gastric emptying, e.g. migraine, Type 1 or Type 2 diabetes mellitus.
- •Any contraindication to gamma scintigraphy.
- •Any non-removable metal objects such as metal plates, screws in the chest or abdominal area.
- •Total radiation dosimetry value which contraindicates participation.
- •Use of prescribed medication within 14 days prior to first dose which could interfere with the study procedures or affect gastric emptying and/or gut transit.
- •Use of over-the-counter (OTC) medication, including vitamins, pro and prebiotics and natural or herbal remedies, within 48 hours prior to first dose.
- •History of alcohol or other substance abuse.
- •Current smoker or recently discontinued smoking (less than 3 months).
- •History of allergy to any component of the dosage form or any other allergy which contraindicates participation.
- •Vegetarian or vegan.
- •Participation in this or another clinical study with an investigational drug within the prior 12 weeks, or more than four other clinical studies in the prior 12 month period.
- •Participants unwilling to comply with contraception requirements from first dose until 90 days (use of condom/spermicide in addition to use of protocol-specified highly effective contraception by female partners who could become pregnant)
研究组 & 干预措施
EDP1815 capsule A (fasted)
In part 1, 12 healthy volunteers will receive a single dose of EDP1815 capsule A, dosed in the fasted state
干预措施: EDP1815 capsule A (Drug)
EDP1815 capsule B (fasted/fed)
In part 1, 2 & 3, 12 healthy volunteers will receive a single dose of EDP1815 capsule B, dosed in the fasted and/or fed state
干预措施: EDP1815 capsule B (Drug)
EDP1815 tablet (fasted/fed)
In part 1, 3 & 4, 12 healthy volunteers will receive a single dose of EDP1815 tablet, dosed in the fasted and/or fed state
干预措施: EDP1815 tablet (Drug)
结局指标
主要结局
Time to onset of radiolabel release
时间窗: up to 12 hours
The time to onset of disintegration/release for each EDP1815 formulation will be measured by using the time of onset of radiolabel release
Site of onset of radiolabel release
时间窗: up to 12 hours
The site of onset of disintegration/release for each EDP1815 formulation will be determined by using the site of onset of radiolabel release
次要结局
- Small intestinal transit time(up to 12 hours)
- Time to 50% release (T50)(up to 12 hours)
- Gastric emptying time(up to 12 hours)
- Time to 90% release (T90)(up to 12 hours)
- Colon arrival time(up to 12 hours)