NCT06556940

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

A Clinical Trial to Assess the Intraluminal Pharmacokinetics of LMN-401 in Individuals With Ileostomies

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Lumen Bioscience, Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Travelers Diarrhea

Interventions

Type	Name	Description
BIOLOGICAL	LMN-401	Orally delivered tablets and capsules

Timeline

• Start date: 2024-12-04
• Primary completion: 2025-10-02
• Completion: 2025-12-02
• First posted: 2024-08-16
• Last updated: 2025-01-09

Locations

1 site across 1 country: Australia