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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06556940




Registration number
NCT06556940
Ethics application status
Date submitted
13/08/2024
Date registered
16/08/2024
Date last updated
9/01/2025

Titles & IDs
Public title
G.I. Pharmacokinetics of LMN-401 in Individuals With Ileostomies
Scientific title
A Clinical Trial to Assess the Intraluminal Pharmacokinetics of LMN-401 in Individuals With Ileostomies
Secondary ID [1] 0 0
TD01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Travelers Diarrhea 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - LMN-401

Experimental: Group 1 - Fast dissolving, uncoated LMN-401 tablets.

Experimental: Group 2 - Slow dissolving, uncoated LMN-401 tablets.

Experimental: Group 3 - Fast dissolving, enterically coated LMN-401 tablets.

Experimental: Group 4 - Slow dissolving, enterically coated LMN-401 tablets.


Treatment: Other: LMN-401
Orally delivered tablets and capsules
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Quantification of LMN-401 components in ileostomy material over time.
Timepoint [1] 0 0
Ten hours post administration of study drug

Eligibility
Key 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
Minimum age
19 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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

Study design
Purpose of the study
Other
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/12/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
2/12/2025
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Coastal Digestive Health Research Institute Pty Ltd - Maroochydore
Recruitment postcode(s) [1] 0 0
4558 - Maroochydore

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Lumen Bioscience, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/study/NCT06556940
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Carl Mason, MD
Address 0 0
Country 0 0
Phone 0 0
2068991904
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06556940