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

Early Phase 1

Recruiting

• Conditions: Travelers Diarrhea
• Interventions: Biological: LMN-401

• Registration Number: NCT06556940
• Lead Sponsor: Lumen Bioscience, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-13
• Study First Submitted QC: 2024-08-13
• Study First Posted: 2024-08-16
• Study Start: 2024-12-04
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-09
• Primary Completion: 2025-10-02
• Study Completion: 2025-12-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 2	LMN-401	-
Group 3	LMN-401	-
Group 1	LMN-401	-
Group 4	LMN-401	-
Group 1	LMN-401	Fast dissolving, uncoated LMN-401 tablets.
Group 3	LMN-401	Fast dissolving, enterically coated LMN-401 tablets.
Group 4	LMN-401	Slow dissolving, enterically coated LMN-401 tablets.
Group 2	LMN-401	Slow dissolving, uncoated LMN-401 tablets.

Primary Outcome Measures

Name	Time	Method
Quantification of LMN-401 components in ileostomy material over time.	Ten hours post administration of study drug	Measurement of individual VHH levels in ileostomy material over time after oral administration of LMN-401

Trial Locations

Locations (1)

Coastal Digestive Health Research Institute Pty Ltd; 🇦🇺 Maroochydore, Australia