Travelers DiarrheaEarly Phase 1NCT06556940
G.I. Pharmacokinetics of LMN-401 in Individuals With Ileostomies
A Early Phase 1 study testing LMN-401 in people with Travelers Diarrhea, run by Lumen Bioscience, Inc. at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Travelers Diarrhea
- What is being tested?
- LMN-401
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteAustralia
- Study dates
- 4 Dec 2024to 2 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Coastal Digestive Health Research Institute Pty Ltd
Maroochydore, 4558
Primary Coordinator, + 7 5408 0900
About this study
Official title: A Clinical Trial to Assess the Intraluminal Pharmacokinetics of LMN-401 in Individuals With Ileostomies
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:
Read more
- 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
- Travelers Diarrhea
- Being tested
- LMN-401
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMN-401Biological
Orally delivered tablets and capsules
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Fast dissolving, uncoated LMN-401 tablets. Receives: Biological: LMN-401 |
| Group 2 | Experimental | Slow dissolving, uncoated LMN-401 tablets. Receives: Biological: LMN-401 |
| Group 3 | Experimental | Fast dissolving, enterically coated LMN-401 tablets. Receives: Biological: LMN-401 |
| Group 4 | Experimental | Slow dissolving, enterically coated LMN-401 tablets. Receives: Biological: LMN-401 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of LMN-401 components in ileostomy material over time.
Measurement of individual VHH levels in ileostomy material over time after oral administration of LMN-401
Measured: Ten hours post administration of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start4 Dec 2024
- Primary completion2 Oct 2025 (estimated)
- Study completion2 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Travelers DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lumen Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06556940
- Sponsor's protocol ID
- TD01
- Status last verified
- Jan 2025
- First submitted
- 13 Aug 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Assess the Intraluminal Pharmacokinetics of LMN-401 in Individuals With Ileostomies
- ClinicalTrials.gov ID
- NCT06556940
- Acronym / sponsor ID
- TD01
- Conditions
- Travelers Diarrhea
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Lumen Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2024 (actual)
- Primary completion
- 2 Oct 2025 (estimated)
- Study completion
- 2 Dec 2025 (estimated)
- First posted
- 16 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: LMN-401Fast dissolving, uncoated LMN-401 tablets. |
| Group 2 | Experimental | Biological: LMN-401Slow dissolving, uncoated LMN-401 tablets. |
| Group 3 | Experimental | Biological: LMN-401Fast dissolving, enterically coated LMN-401 tablets. |
| Group 4 | Experimental | Biological: LMN-401Slow dissolving, enterically coated LMN-401 tablets. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LMN-401Orally delivered tablets and capsules | Biological | Group 1, Group 2, Group 3, Group 4 |
Primary outcome
Quantification of LMN-401 components in ileostomy material over time.
Time frame: Ten hours post administration of study drug
Measurement of individual VHH levels in ileostomy material over time after oral administration of LMN-401
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LMN-401 in people with Travelers Diarrhea, run by Lumen Bioscience, Inc. at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carl Mason, MD (2068991904, cmason@lumen.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of LMN-401 components in ileostomy material over time. (time frame: Ten hours post administration of study drug). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.