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

Lumen Bioscience

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Travelers Diarrhea

Treatments: Biological: LMN-401

Study type: Interventional

Funder types: Industry

Identifiers

NCT06556940

TD01

Details and patient eligibility

About

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.

Enrollment: 12 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

12 participants in 4 patient groups

Group 1

Experimental group

Treatment:

Biological: LMN-401

Group 2

Experimental group

Treatment:

Biological: LMN-401

Group 3

Experimental group

Treatment:

Biological: LMN-401

Group 4

Experimental group

Treatment:

Biological: LMN-401