The purpose of this study is to determine whether DAV132 is safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
44
DAV132 is associated to moxifloxacin or it is evaluated alone
Moxifloxacin is used alone or associated to DAV132
Moxifloxacin is used alone
CLINICAL INVESTIGATION CENTER (CIC), Groupe Hospitalier Bichat-Claude Bernard
Paris, France
Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 16 Days After the Beginning of Treatment (AUC D1-D16)
Time frame: D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16
Moxifloxacin Fecal Pharmacokinetics: Area Under the Free Moxifloxacin Fecal Concentration-time Curve Over the Period Time From Beginning of Treatment to 37 Days After the Beginning of Treatment (AUC D1-D37)
Time frame: D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16, D23, D30, D37
Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D1
Time frame: D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose
Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D5
Time frame: D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose
Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D1
Time frame: D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose
Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D5
Time frame: D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose
Number of Adverse Events (Including Abnormal Laboratory Findings) Related to Study Product
Time frame: From randomization to 37 days after the beginning of treatment
Percentage of Subjects With Adverse Events Related to Study Product
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Time frame: From randomization to 37 days after the beginning of treatment