Status:
RECRUITING
G.I. Pharmacokinetics of LMN-401 in Individuals With Ileostomies
Lead Sponsor:
Lumen Bioscience, Inc.
Conditions:
Travelers Diarrhea
Eligibility:
All Genders
19+ years
Phase:
EARLY_PHASE1
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 develo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 2 2025
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT06556940
Start Date
December 4 2024
End Date
December 2 2025
Last Update
January 9 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Coastal Digestive Health Research Institute Pty Ltd
Maroochydore, Australia, 4558