NCT02176005

Safety and Efficacy Study of DAV132 in Healthy Volunteers

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Da Volterra · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DEVICE	DAV132	DAV132 is associated to moxifloxacin or it is evaluated alone
DRUG	Moxifloxacin	Moxifloxacin is used alone or associated to DAV132
OTHER	Negative Control	Moxifloxacin is used alone

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-10-01
• Completion: 2014-12-01
• First posted: 2014-06-26
• Last updated: 2020-02-28
• Results posted: 2020-02-28

Locations

1 site across 1 country: France