Safety and Efficacy Study of DAV132 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy
• Interventions: Device: DAV132; Other: Negative Control; Drug: Moxifloxacin

• Registration Number: NCT02176005
• Lead Sponsor: Da Volterra

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.

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-06-25
• Study First Submitted QC: 2014-06-25
• Study First Posted: 2014-06-26
• Primary Completion: 2014-10
• Study Completion: 2014-12
• Results First Submitted: 2019-07-05
• Status Verified: 2020-02
• Results First Submitted QC: 2020-02-16
• Last Update Submitted: 2020-02-16
• Results First Posted: 2020-02-28
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Healthy volunteers
• Normal digestive transit, with usually one daily stool.
• Females participating in the study :

must be either of non-child bearing potential (surgically sterilized at least 3 months prior to inclusion, or postmenopausal or having a negative pregnancy test and be not breastfeeding at screening, and using abstinence or a double contraception method during the treatment period and for additional period of 2 weeks after the end of investigational treatment.

• Having given and signed the written study informed consent prior to undertaking any study-related procedure.
• Covered by the French Health Insurance system.

Exclusion Criteria

• Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, haematological, neurological, bone and joint, muscular, psychiatric, systemic, ocular, gynaecologic (if female), or infectious disease, or signs of acute illness.
• Contra-indications to fluoroquinolones, or risk factors for adverse events associated to fluoroquinolones.
• Subjects with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency should be excluded.
• Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should be excluded.
• Contra-indications to DAV132, risk of gastrointestinal obstruction, perforation or haemorrhage, recent digestive tract surgery.
• Fecal colonisation by Clostridium difficile.
• Recent history of hospitalisation (within 3 months prior to inclusion).
• Any antibiotic administration within 3 months before inclusion.
• Any vaccination within the last 28 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
moxifloxacin + DAV132	DAV132	Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days
DAV132	DAV132	DAV132 oral, 7.5g x3/day for 7 days
Negative control	Negative Control	Negative control: 7.5g x3/day for 7 days
Moxifloxacin	Moxifloxacin	Moxifloxacin, oral tablets, 400mg/day, once daily 5 days
moxifloxacin + DAV132	Moxifloxacin	Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days

Primary Outcome Measures

Name	Time	Method
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)	D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16

Secondary Outcome Measures

Name	Time	Method
Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D5	D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose
Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D1	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	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	From randomization to 37 days after the beginning of treatment
Percentage of Subjects With Adverse Events Related to Study Product	From randomization to 37 days after the beginning of treatment
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)	D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16, D23, D30, D37
Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D1	D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose

Trial Locations

Locations (1)

CLINICAL INVESTIGATION CENTER (CIC), Groupe Hospitalier Bichat-Claude Bernard; 🇫🇷 Paris, France