Ignite Creation Date:
2024-05-06 @ 2:03 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04192487
Status:
COMPLETED
Last Update Posted:
2021-10-22
First Post:
2019-11-04
Brief Title:
Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in HIV Patients With Non-Infectious Diarrhea
Sponsor:
Napo Pharmaceuticals Inc
Organization:
Napo Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 4 Open Label Study to Assess the Safety and Effects of Crofelemer on the Gut Microbiome in Healthy Volunteers and in People Living With HIVAIDS PLWHA With Non-Infectious Diarrhea
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is intended to evaluate
1 Any changes in the gut microbiome from baseline compared to end of study in both healthy HIV-negative subjects and HIV patients with or without chronic diarrhea following one month of treatment with crofelemer Mytesi delayed release 125 mg tablets twice daily BID following one month of treatment
2 The safety and tolerability of crofelemer Mytesi delayed release 125 mg tablets BID in healthy HIV-negative volunteers and HIV patients following one month of treatment
1 Any changes in the gut microbiome from baseline compared to end of study in both healthy HIV-negative subjects and HIV patients with or without chronic diarrhea following one month of treatment with crofelemer Mytesi delayed release 125 mg tablets twice daily BID following one month of treatment
2 The safety and tolerability of crofelemer Mytesi delayed release 125 mg tablets BID in healthy HIV-negative volunteers and HIV patients following one month of treatment
Detailed Description:
Mytesi crofelemer is an FDA-approved anti-diarrheal drug indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIVAIDS on combination anti-retroviral therapy CART Crofelemer a first-in-class intraluminally active use-dependent chloride Cl- ion channel modulator that produces an antidiarrheal effect by reducing Cl- secretion and the accompanying high-volume fluid secretion into the GI lumen
This Phase 4 trial will explore the induced gut microbiome changes in comparison to a group of normal healthy volunteers also receiving crofelemer delayed release 125 mg tablets twice daily for 30 days
This is a non-randomized study The study will enroll approximately 24 male or female subjects aged at least 18 years in three cohorts of approximately 8 subjects each
This Phase 4 trial will explore the induced gut microbiome changes in comparison to a group of normal healthy volunteers also receiving crofelemer delayed release 125 mg tablets twice daily for 30 days
This is a non-randomized study The study will enroll approximately 24 male or female subjects aged at least 18 years in three cohorts of approximately 8 subjects each
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None