Investigating the drug LMN-401 in individuals with ileostomies
A Clinical Trial to Assess the Intraluminal Pharmacokinetics of LMN-401 in Individuals With Ileostomies
This study is testing how well a new drug called LMN-401 works in adults with ileostomies to see how it's absorbed and if it's safe to use.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Lumen Bioscience, Inc. Industry-sponsored |
| Locations | 1 site (Maroochydore) |
| Trial ID | NCT06556940 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to understand the pharmacokinetics of the investigational drug LMN-401 in adult healthy volunteers who have ileostomies. The study will assess how the drug is absorbed and metabolized in the body by analyzing ileostomy material after administration of LMN-401 in different tablet formulations. Additionally, it will evaluate the safety and tolerability of LMN-401 in this specific population, considering factors such as the participants' fed or fasted state during the study.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 19 years and older with stable ileostomies.
Not a fit: Patients with clinically significant diseases or those using anti-diarrheal medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for Traveler's Diarrhea.
How similar studies have performed: While this approach is novel in the context of ileostomies, similar pharmacokinetic studies have shown promise in other populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Maroochydore
- Coastal Digestive Health Research Institute Pty Ltd — Maroochydore, Australia (Recruiting)
Study contacts
- Study coordinator: Carl Mason, MD
- Email: cmason@lumen.bio
- Phone: 2068991904
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.