Safety and Efficacy Study of DAV132 in Healthy Volunteers

• ClinicalTrials.gov Identifier: NCT02176005
• Recruitment Status: Completed
• First Posted: June 26, 2014
• Results First Posted: February 28, 2020
• Last Update Posted: February 28, 2020
• Sponsor: Da Volterra
• Information provided by (Responsible Party): Da Volterra

Study Description

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 Design

• 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

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. 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 ]

Secondary Outcome Measures :

1. 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 ]
2. 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 ]
3. 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 ]
4. 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 ]
5. 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 ]
6. Number of Adverse Events (Including Abnormal Laboratory Findings) Related to Study Product [ Time Frame: From randomization to 37 days after the beginning of treatment ]
7. Percentage of Subjects With Adverse Events Related to Study Product [ Time Frame: From randomization to 37 days after the beginning of treatment ]

Eligibility Criteria

• 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.

Contacts and Locations

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

More Information

Publications:

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.

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Da Volterra
• ClinicalTrials.gov Identifier: NCT02176005
• Other Study ID Numbers: DAV132-CL-1002; ID-RCB number 2013-A01504-41 ( Other Identifier: ANSM (French Agency) )
• First Posted: June 26, 2014
• Results First Posted: February 28, 2020
• Last Update Posted: February 28, 2020
• Last Verified: February 2020

Additional relevant MeSH terms:

Moxifloxacin; Anti-Bacterial Agents; Anti-Infective Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents