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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
25/03/2025

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.
Assessment method [1] 0 0
Measurement of individual VHH levels in ileostomy material over time after oral administration of LMN-401
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.
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 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
Email 0 0
cmason@lumen.bio
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06556940