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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age19+
SponsorLumen Bioscience, Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Unable or unwilling to provide adequate informed consent

Gastroparesis

Using or planning to use anti-diarrheal medication

Using or planning to use opioids

Trial design

Design model

Crossover

Treatments tested in this trial

  • LMN-401

    Biological/Vaccine

    Orally delivered tablets and capsules

Treatment groups

12 Participants
are divided into 4 treatment groups
Group A: Group 1Experimental treatment 1 intervention
Group B: Group 2Experimental treatment 1 intervention
Group C: Group 3Experimental treatment 1 intervention
Group D: Group 4Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Quantification of LMN-401 components in ileostomy material over time.

Measurement of individual VHH levels in ileostomy material over time after oral administration of LMN-401

Time frame
Ten hours post administration of study drug

Secondary outcomes

Other outcomes

Sponsors and contacts

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