Safety and Efficacy Study of DAV132 in Healthy Volunteers

NCT ID: NCT02176005

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2014-12-31

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Moxifloxacin

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

Group Type: ACTIVE_COMPARATOR

Moxifloxacin

Intervention Type: DRUG

Moxifloxacin is used alone or associated to DAV132

moxifloxacin + DAV132

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

Group Type: EXPERIMENTAL

DAV132

Intervention Type: DEVICE

DAV132 is associated to moxifloxacin or it is evaluated alone

Moxifloxacin

Intervention Type: DRUG

Moxifloxacin is used alone or associated to DAV132

DAV132

DAV132 oral, 7.5g x3/day for 7 days

Group Type: EXPERIMENTAL

DAV132

Intervention Type: DEVICE

DAV132 is associated to moxifloxacin or it is evaluated alone

Negative control

Negative control: 7.5g x3/day for 7 days

Group Type: PLACEBO_COMPARATOR

Negative Control

Intervention Type: OTHER

Moxifloxacin is used alone

Interventions

DAV132

DAV132 is associated to moxifloxacin or it is evaluated alone

Intervention Type: DEVICE

Moxifloxacin

Moxifloxacin is used alone or associated to DAV132

Intervention Type: DRUG

Negative Control

Moxifloxacin is used alone

Intervention Type: OTHER

Other Intervention Names

Avelox

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Da Volterra

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier Duval, MD

Role: PRINCIPAL_INVESTIGATOR

CIC Bichat, Paris France

Locations

CLINICAL INVESTIGATION CENTER (CIC), Groupe Hospitalier Bichat-Claude Bernard

Paris, , France

Countries

France

References

Edlund C, Beyer G, Hiemer-Bau M, Ziege S, Lode H, Nord CE. Comparative effects of moxifloxacin and clarithromycin on the normal intestinal microflora. Scand J Infect Dis. 2000;32(1):81-5. doi: 10.1080/00365540050164272.

Reference Type: BACKGROUND

PMID: 10716083 (View on PubMed)

Burkhardt O, Borner K, Stass H, Beyer G, Allewelt M, Nord CE, Lode H. Single- and multiple-dose pharmacokinetics of oral moxifloxacin and clarithromycin, and concentrations in serum, saliva and faeces. Scand J Infect Dis. 2002;34(12):898-903. doi: 10.1080/0036554021000026963.

Reference Type: BACKGROUND

PMID: 12587622 (View on PubMed)

de Gunzburg J, Ghozlane A, Ducher A, Le Chatelier E, Duval X, Ruppe E, Armand-Lefevre L, Sablier-Gallis F, Burdet C, Alavoine L, Chachaty E, Augustin V, Varastet M, Levenez F, Kennedy S, Pons N, Mentre F, Andremont A. Protection of the Human Gut Microbiome From Antibiotics. J Infect Dis. 2018 Jan 30;217(4):628-636. doi: 10.1093/infdis/jix604.

Reference Type: DERIVED

PMID: 29186529 (View on PubMed)

Other Identifiers

ID-RCB number 2013-A01504-41

Identifier Type: OTHER

Identifier Source: secondary_id

DAV132-CL-1002

Identifier Type: -

Identifier Source: org_study_id