Travelers Diarrhea
Conditions
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.
Interventions
BIOLOGICALLMN-401
Orally delivered tablets and capsules
Sponsors
Lumen Bioscience, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia
Contacts
Primary ContactCarl Mason, MD
Backup ContactAsa Davis, PhD
Outcome results
None listed