Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06556940
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-13
Brief Title:
GI Pharmacokinetics of LMN-401 in Individuals With Ileostomies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Clinical Trial to Assess the Intraluminal Pharmacokinetics of LMN-401 in Individuals With Ileostomies
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Travelers 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 participants 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
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 participants 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None