Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2026-03-04 @ 11:48 AM
Study NCT ID:
NCT02176005
Status:
COMPLETED
Last Update Posted:
2020-02-28
First Post:
2014-06-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of DAV132 in Healthy Volunteers
Sponsor:
Da Volterra
Organization:
Study Overview
Official Title:
Influence of the Administration of DAV132 7.5g Tid for 7 Days on the Fecal Levels of Moxifloxacin During and After a 5-day Oral Treatment With Moxifloxacin 400mg Oad in Healthy Volunteers
Status:
COMPLETED
Status Verified Date:
2020-02
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:
The purpose of this study is to determine whether DAV132 is safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.
Detailed Description:
The proposed study, DAV132-CL-1002, is to evaluate performances of DAV132 in healthy volunteers:
* To capture residual concentration of antibiotics in colon without interfering with their systemic pharmacokinetics parameters.
* To explore the influence of DAV132 to prevent the modification of gut flora due to antibiotic.
In addition, the security and acceptability of DAV132 used during 7 days will be evaluated.
The proposed study is prospective, randomized, controlled, four parallel groups, repeated doses, open-label study blinded to analytical and microbiological evaluations.
* To capture residual concentration of antibiotics in colon without interfering with their systemic pharmacokinetics parameters.
* To explore the influence of DAV132 to prevent the modification of gut flora due to antibiotic.
In addition, the security and acceptability of DAV132 used during 7 days will be evaluated.
The proposed study is prospective, randomized, controlled, four parallel groups, repeated doses, open-label study blinded to analytical and microbiological evaluations.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| ID-RCB number 2013-A01504-41 | OTHER | ANSM (French Agency) | View |