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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Fast dissolving, uncoated LMN-401 tablets. |
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| Group 2 | Experimental | Slow dissolving, uncoated LMN-401 tablets. |
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| Group 3 | Experimental | Fast dissolving, enterically coated LMN-401 tablets. |
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| Group 4 | Experimental | Slow dissolving, enterically coated LMN-401 tablets. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LMN-401 | Biological | Orally delivered tablets and capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Ten hours post administration of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carl Mason, MD | Contact | 2068991904 | cmason@lumen.bio | |
| Asa Davis, PhD | Contact | 2068991904 | adavis@lumen.bio |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Coastal Digestive Health Research Institute Pty Ltd | Recruiting | Maroochydore | 4558 | Australia |
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