G.I. Pharmacokinetics of LMN-401 in Individuals With Ileostomies

January 7, 2025 updated by: Lumen Bioscience, Inc.

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:

  • 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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Maroochydore, Australia, 4558
        • Recruiting
        • Coastal Digestive Health Research Institute Pty Ltd
        • Contact:
          • Primary Coordinator
          • Phone Number: + 7 5408 0900

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group 1
Fast dissolving, uncoated LMN-401 tablets.
Biological: LMN-401
Orally delivered tablets and capsules
Experimental: Group 2
Slow dissolving, uncoated LMN-401 tablets.
Biological: LMN-401
Orally delivered tablets and capsules
Experimental: Group 3
Fast dissolving, enterically coated LMN-401 tablets.
Biological: LMN-401
Orally delivered tablets and capsules
Experimental: Group 4
Slow dissolving, enterically coated LMN-401 tablets.
Biological: LMN-401
Orally delivered tablets and capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Ten hours post administration of study drug

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lumen Bioscience, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2024

Primary Completion (Estimated)

October 2, 2025

Study Completion (Estimated)

December 2, 2025

Study Registration Dates

First Submitted

August 13, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TD01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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