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

Recruiting now · Early Phase 1

Conditions studied: Travelers Diarrhea

In brief

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.

Key facts

Study ID

NCT06556940

Run by

Lumen Bioscience, Inc.

People needed

12

Starts

2024-12-04

Expected to finish

2025-12-02

Last updated by the study team

2025-01-09

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Coastal Digestive Health Research Institute Pty Ltd — Maroochydore, Australia (enrolling)

Full record on ClinicalTrials.gov

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