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Safety and Efficacy Study of DAV132 in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT02176005
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Healthy Device: DAV132 Drug: Moxifloxacin Other: Negative Control Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : March 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Moxifloxacin
Moxifloxacin, oral tablets, 400mg/day, once daily 5 days
Drug: Moxifloxacin
Moxifloxacin is used alone or associated to DAV132
Other Name: Avelox

Experimental: moxifloxacin + DAV132
Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days
Device: DAV132
DAV132 is associated to moxifloxacin or it is evaluated alone

Drug: Moxifloxacin
Moxifloxacin is used alone or associated to DAV132
Other Name: Avelox

Experimental: DAV132
DAV132 oral, 7.5g x3/day for 7 days
Device: DAV132
DAV132 is associated to moxifloxacin or it is evaluated alone

Placebo Comparator: Negative control
Negative control: 7.5g x3/day for 7 days
Other: Negative Control
Moxifloxacin is used alone




Primary Outcome Measures :
  1. The area under the free moxifloxacin concentration-time curve over the period time from beginning of treatment to 16 days after the beginning of treatment. [ Time Frame: 16 days after the beginning of treatment ]

Secondary Outcome Measures :
  1. The area under the free moxifloxacin concentration-time curve over the period time from beginning of treatment to 37 days after the beginning of treatment [ Time Frame: 37 days after the begenning of treatment ]

Other Outcome Measures:
  1. Number of adverse events (including abnormal laboratory findings) and percentage of subjects with at least one adverse event [ Time Frame: From starting screening to 37 days after the beginning of treatment ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02176005


Locations
France
CLINICAL INVESTIGATION CENTER (CIC), Groupe Hospitalier Bichat-Claude Bernard
Paris, France, 75O18
Sponsors and Collaborators
Da Volterra
Investigators
Principal Investigator: Xavier Duval, MD CIC Bichat, Paris France

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Da Volterra
ClinicalTrials.gov Identifier: NCT02176005     History of Changes
Other Study ID Numbers: DAV132-CL-1002
ID-RCB number 2013-A01504-41 ( Other Identifier: ANSM (French Agency) )
First Posted: June 26, 2014    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Moxifloxacin
Fluoroquinolones
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Nucleic Acid Synthesis Inhibitors