Actively Recruiting
A Clinical Trial to Assess the Intraluminal Pharmacokinetics of LMN-401 in Individuals With Ileostomies
Led by Lumen Bioscience, Inc. · Updated on 2025-01-09
12
Participants Needed
1
Research Sites
51 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the intraluminal pharmacokinetics of the investigational drug LMN-401 in adults with ileostomies. LMN-401 is being developed as a possible new treatment for Traveler's Diarrhea. This early phase 1 study aims to understand how much and when components of LMN-401 appear in ileostomy material and to assess the safety and tolerability of the drug in healthy volunteers. Participants will receive LMN-401 in orally delivered tablets and capsules formulated with different properties. The study will compare the timing and amount of drug components found in ileostomy material after dosing, considering whether participants are in a fed or fasted state. Each participant will attend four study visits to receive the investigational product and provide samples. During each visit, ileostomy material will be collected before dosing and every two hours for 10 hours after taking the drug. Researchers will quantify LMN-401 components in the collected material over time. Participants will be monitored for safety and tolerability throughout the study. The total duration and follow-up details are based on these four visits and sample collections.
CONDITIONS
Official Title
G.I. Pharmacokinetics of LMN-401 in Individuals With Ileostomies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Coastal Digestive Health Research Institute Pty Ltd
Maroochydore, Australia, 4558
Actively Recruiting
Research Team
C
Carl Mason, MD
A
Asa Davis, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
CROSSOVER
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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