A Clinical Trial to Assess the Intraluminal Pharmacokinetics of LMN-401 in Individuals With Ileostomies
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Quantification of LMN-401 components in ileostomy material over time.
研究概览
简要总结
The goal of this interventional study is to learn about the intraluminal pharmacokinetics (PK) of the investigational drug LMN-401 in adult healthy volunteers with ileostomies. LMN-401 is being developed as a potential new treatment for Traveler's Diarrhea. The study will also learn about the safety of the investigational drug LMN-401.
The main questions it aims to answer are:
- What is the timing and amount of components of investigational drug LMN-401 detected in the collected ileostomy material?
- Is LMN-401 safe and well tolerated in healthy volunteers taking the investigational drug?
Researchers will compare the timing and amount of investigational drug components detected in the ileostomy material in volunteers taking the investigational drug LMN-401 formulated into tablets with different properties. The impact of the study participant's fed or fasted state on the timing and amount of drug components detected in the ileostomy material will also be evaluated.
Each study participant will come into the research clinic for four study visits. Study participants will receive the investigational product formulated into tablets with different properties. Ileostomy material will be collected at baseline (pre-dose) and every two hours after investigational product dose administration for 10 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 19 years and above
- •Medically stable
- •Mature and stable ileostomy (no revisions in past 6 months)
- •Willing and able to participate in all study visits
- •Willing and able to provide informed consent
排除标准
- •Unable or unwilling to provide adequate informed consent
- •Gastroparesis
- •Using or planning to use anti-diarrheal medication
- •Using or planning to use opioids
- •Clinically significant disease
- •Women who are pregnant, intending to become pregnant, or breastfeeding
- •Non-English speakers
研究组 & 干预措施
Group 1
Fast dissolving, uncoated LMN-401 tablets.
干预措施: LMN-401 (Biological)
Group 2
Slow dissolving, uncoated LMN-401 tablets.
干预措施: LMN-401 (Biological)
Group 3
Fast dissolving, enterically coated LMN-401 tablets.
干预措施: LMN-401 (Biological)
Group 4
Slow dissolving, enterically coated LMN-401 tablets.
干预措施: LMN-401 (Biological)
结局指标
主要结局
Quantification of LMN-401 components in ileostomy material over time.
时间窗: Ten hours post administration of study drug
Measurement of individual VHH levels in ileostomy material over time after oral administration of LMN-401
次要结局
未报告次要终点