Actively Recruiting
G.I. 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
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
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
AI-Powered 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
CONTACT
A
Asa Davis, PhD
CONTACT
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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