NCT02917200

Safety and Efficacy Study of Different DAV132 Dose Regimens in Healthy Volunteers

Impact of Different DAV132 Dose Regimens (From 2 to 22.5 g/Day During 7 Days, Bid and Tid) on the Fecal Moxifloxacin Concentrations and the Intestinal Microbiota of Healthy Volunteers Treated With Moxifloxacin 400 mg/Day During 5 Days

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Da Volterra · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate whether different DAV132 dose regimens are safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.

Detailed description

The aim of the study is to evaluate the performances of different DAV132 dose regimens in healthy volunteers: * To capture antibiotic residues in the colon without interfering with its systemic pharmacokinetics. * To prevent antibiotic-induced changes of the intestinal microbiota. In addition, the security of DAV132 given at different dose regimens during 7 days will be evaluated. This is a prospective, randomized, controlled, repeated doses, 12 parallel groups, open-label study, blinded to analytical and microbiological evaluations.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
DRUG	Moxifloxacin	Oral route
DEVICE	DAV132	Oral route
OTHER	Negative control	Oral route

Timeline

• Start date: 2016-05-11
• Primary completion: 2016-12-02
• Completion: 2016-12-02
• First posted: 2016-09-28
• Last updated: 2017-09-12

Locations

1 site across 1 country: France