G.I. Pharmacokinetics of LMN-401 in Individuals With Ileostomies
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LMN-401.
- Who it may be relevant to
- Registry conditions: Travelers Diarrhea. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Clinical Trial to Assess the Intraluminal Pharmacokinetics of LMN-401 in Individuals With Ileostomies
Overview
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.
Interventions
- Biological LMN-401
Orally delivered tablets and capsules
Primary outcome measures
- Quantification of LMN-401 components in ileostomy material over time. [Time frame: Ten hours post administration of study drug]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
Australia · 1 center
- Coastal Digestive Health Research Institute Pty Ltd — Maroochydore
Identifiers
NCT: NCT06556940 · TD01