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

NCT06556940 | Recruiting Early Phase 1

• 1 other identifier: TD01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Travelers Diarrhea

Outcome Measures

Primary Outcomes (1)

• 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

  Ten hours post administration of study drug

Study Arms (4)

Group 1

EXPERIMENTAL

Fast dissolving, uncoated LMN-401 tablets.

Biological: LMN-401

Group 2

EXPERIMENTAL

Slow dissolving, uncoated LMN-401 tablets.

Biological: LMN-401

Group 3

EXPERIMENTAL

Fast dissolving, enterically coated LMN-401 tablets.

Biological: LMN-401

Group 4

EXPERIMENTAL

Slow dissolving, enterically coated LMN-401 tablets.

Biological: LMN-401

Interventions

LMN-401 BIOLOGICAL

Orally delivered tablets and capsules

Group 1; Group 2; Group 3; Group 4

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lumen Bioscience, Inc.: lead

Study Sites (1)

Coastal Digestive Health Research Institute Pty Ltd

Maroochydore, 4558, Australia

RECRUITING

Central Study Contacts

Carl Mason, MD

CONTACT

2068991904; cmason@lumen.bio

Asa Davis, PhD

CONTACT

2068991904; adavis@lumen.bio

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 16, 2024
• Study Start: December 4, 2024
• Primary Completion: October 2, 2025
• Study Completion: December 2, 2025
• Last Updated: January 9, 2025

Record last verified: 2025-01

Locations

AU (1)