Coastal Digestive Health Research Institute Pty Ltd
Maroochydore, 4558, Australia
Location status: Recruiting
NCT Number: NCT06556940
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.
Interested in participating?
Request Info19 year and older
All sexes
Interventional
Early Phase 1
Maroochydore, 4558, Australia
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Orally delivered tablets and capsules
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
Contact information is provided by the study sponsor or research team.
Asa Davis, PhD
CONTACT
Carl Mason, MD
CONTACT
Lumen Bioscience, Inc.
Industry
A Clinical Trial to Assess the Intraluminal Pharmacokinetics of LMN-401 in Individuals With Ileostomies
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.
Published trials that share one or more normalized conditions with this study.
NCT06363890
Travelers Diarrhea
Melbourne, Australia
View Trial DetailsNCT05933525
Diarrhea, Digestive System Diseases
Baltimore, Maryland, United States
View Trial Details