A Clinical Trial to Assess the Intraluminal Pharmacokinetics of LMN-401 in Individuals With Ileostomies

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: t
View:

• 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

Locations
Other Locations
Australia
Coastal Digestive Health Research Institute Pty Ltd
RECRUITING
Maroochydore
Contact Information
Primary
Carl Mason, MD
cmason@lumen.bio
2068991904
Backup
Asa Davis, PhD
adavis@lumen.bio
2068991904
Time Frame
Start Date: 2024-12-04
Estimated Completion Date: 2025-12-02
Participants
Target number of participants: 12
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Lumen Bioscience, Inc.

This content was sourced from clinicaltrials.gov

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