G.I. Pharmacokinetics of LMN-401 in Individuals With Ileostomies

Launched by LUMEN BIOSCIENCE, INC. · Aug 13, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called LMN-401, which is being developed as a potential treatment for Traveler’s Diarrhea. The researchers want to understand how the drug behaves in the body, specifically in individuals who have had surgery to create an ileostomy (an opening in the abdomen to help with waste removal). They will check how much of the drug is found in the waste collected from the ileostomy and whether the drug is safe for healthy volunteers.

To participate in this study, individuals must be at least 19 years old, have a stable ileostomy that hasn’t changed in the last six months, and be willing to attend four clinic visits. During these visits, participants will take tablets containing the investigational drug, and researchers will collect samples from their ileostomy at different times after taking the medication. This study will help determine the best way to use LMN-401 for treating Traveler’s Diarrhea and ensure it’s safe for people to use.

Gender

ALL

Eligibility 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