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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the investigational drug LMN-401 to understand how it behaves inside the intestines of adult healthy volunteers with ileostomies. This study focuses on measuring the timing and amount of drug components found in ileostomy material and assessing the safety of LMN-401. The drug is being developed as a potential new treatment for Traveler's Diarrhea. Participants will receive LMN-401 tablets formulated with different dissolving properties: fast dissolving uncoated, slow dissolving uncoated, fast dissolving enterically coated, and slow dissolving enterically coated tablets. The study will also evaluate how eating or fasting affects the drug's presence in ileostomy material. Each participant will attend four clinic visits to receive these different formulations. During each visit, ileostomy material will be collected before taking the drug and then every two hours for ten hours after dosing. Researchers will measure the amount of LMN-401 components in these samples over time. Participants will be monitored for safety and tolerability throughout the study, which runs from December 2024 to December 2025.
CONDITIONS
Brief 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 with no revisions in the 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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 10 hours post administration per formulation
Participants receive different formulations of LMN-401 tablets to assess gastrointestinal pharmacokinetics.
1 visit per formulation, up to 4 visits total
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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