Safety and Efficacy Study of DAV132 in Healthy Volunteers

Da Volterra

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Other: Negative Control; Drug: Moxifloxacin; Device: DAV132

Study type: Interventional

Funder types: Industry

Identifiers

NCT02176005

DAV132-CL-1002

ID-RCB number 2013-A01504-41 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine whether DAV132 is safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 4 patient groups, including a placebo group

Moxifloxacin

Active Comparator group

Description:

Moxifloxacin, oral tablets, 400mg/day, once daily 5 days

Treatment:

Drug: Moxifloxacin

moxifloxacin + DAV132

Experimental group

Description:

Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days

Treatment:

Device: DAV132

Drug: Moxifloxacin

DAV132

Experimental group

Description:

DAV132 oral, 7.5g x3/day for 7 days

Treatment:

Device: DAV132

Negative control

Placebo Comparator group

Description:

Negative control: 7.5g x3/day for 7 days

Treatment:

Other: Negative Control