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NCT Number: NCT06556940

G.I. 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.

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Coastal Digestive Health Research Institute Pty Ltd

Maroochydore, 4558, Australia

Location status: Recruiting

Location contact

Primary Coordinator

CONTACT

+ 7 5408 0900

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LMN-401

Biological

Orally delivered tablets and capsules

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Asa Davis, PhD

CONTACT

[email protected]

2068991904

Carl Mason, MD

CONTACT

[email protected]

2068991904

Sponsors and collaborators

Lead sponsor

Lumen Bioscience, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 16, 2024
Registry last updated
Jan 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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