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| ID | Type | Description | Link |
|---|---|---|---|
| ID-RCB number 2013-A01504-41 | Other Identifier | ANSM (French Agency) |
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The purpose of this study is to determine whether DAV132 is safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.
The proposed study, DAV132-CL-1002, is to evaluate performances of DAV132 in healthy volunteers:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin | Active Comparator | Moxifloxacin, oral tablets, 400mg/day, once daily 5 days |
|
| moxifloxacin + DAV132 | Experimental | Moxifloxacin : 400mg/day for 5 days DAV132: 7.5g x3/day for 7 days |
|
| DAV132 | Experimental | DAV132 oral, 7.5g x3/day for 7 days |
|
| Negative control | Placebo Comparator | Negative control: 7.5g x3/day for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DAV132 | Device | DAV132 is associated to moxifloxacin or it is evaluated alone |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D1 |
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Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xavier Duval, MD | CIC Bichat, Paris France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CLINICAL INVESTIGATION CENTER (CIC), Groupe Hospitalier Bichat-Claude Bernard | Paris | 75O18 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10716083 | Background | 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. | |
| 12587622 | Background | 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. |
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Healthy volunteers were recruited from March 20th, 2014 (date of first enrolment) and October 17th, 2014 (date of last completed)
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| ID | Title | Description |
|---|---|---|
| FG000 | Moxifloxacin | Moxifloxacin (oral tablets, 400mg x1/day for 5 days) used alone |
| FG001 | DAV132 + Moxifloxacin | DAV132 (7.5g x3/day taken orally for 7 days) associated to Moxifloxacin (400mg x1/day taken orally for 5 days) |
| FG002 | DAV132 | DAV132 (7.5g x3/day taken orally for 7 days) used alone |
| FG003 | Negative Control | Negative control: microcrystalline cellulose (7.5g x3/day taken orally for 7 days) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Moxifloxacin | Moxifloxacin (400mg x1/day taken orally for 5 days) used alone |
| BG001 | DAV132 + Moxifloxacin | DAV132 (7.5g x3/day taken orally for 7 days) associated to Moxifloxacin (400mg x1/day taken orally for 5 days) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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) | Posted | Mean | Standard Deviation | μg/g.day | D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16 |
|
Treatment period: - 5 days for Moxifloxacin group; - 7 days for the 3 other groups (DAV132 + Moxifloxacin, DAV132 and Negative Control groups)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moxifloxacin | Moxifloxacin (400mg x1/day taken orally for 5 days) used alone | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Annie Ducher, Chief Medical Officer | Da Volterra | +33 1 58 39 32 20 | annie.ducher@davolterra.com |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Moxifloxacin | Drug | Moxifloxacin is used alone or associated to DAV132 |
|
|
| Negative Control | Other | Moxifloxacin is used alone |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 29186529 | Derived | 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. |
| BG002 | DAV132 | DAV132 (7.5g x3/day taken orally for 7 days) used alone |
| BG003 | Negative Control | Negative control: microcrystalline cellulose (7.5g x3/day taken orally for 7 days) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) at screening visit | Mean | Standard Deviation | kg/m^2 |
|
|
|
|
| Secondary | 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) | Posted | Mean | Standard Deviation | μg/g.day | D1 pre-dose, D2, D3, D4, D5, D6, D7, D8, D9, D12, D16, D23, D30, D37 |
|
|
|
|
| Secondary | Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D1 | Posted | Mean | Standard Deviation | µg/mL.h | D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose |
|
|
|
|
| Secondary | Moxifloxacin Plasma Pharmacokinetics: AUC(0-24h) of Moxifloxacin Plasma Concentrations Over Time on D5 | Posted | Mean | Standard Deviation | µg/mL.h | D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose |
|
|
|
|
| Secondary | Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D1 | Posted | Mean | Standard Deviation | µg/mL | D1: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h and 24h post-dose |
|
|
|
|
| Secondary | Moxifloxacin Plasma Pharmacokinetics: Cmax of Moxifloxacin in Plasma on D5 | Posted | Mean | Standard Deviation | µg/mL | D5: at pre-dose; 0h30; 1h; 1h30; 2h; 3h; 4h; 6h; 12h; 24h; 32h; 48h; 56h and 72h post-dose |
|
|
|
|
| Secondary | Number of Adverse Events (Including Abnormal Laboratory Findings) Related to Study Product | Posted | Number | events related to study product | From randomization to 37 days after the beginning of treatment |
|
|
|
| Secondary | Percentage of Subjects With Adverse Events Related to Study Product | Posted | Number | % of subjects with at last 1 related AE | From randomization to 37 days after the beginning of treatment |
|
|
|
| 14 |
| 0 |
| 14 |
| 6 |
| 14 |
| EG001 | Moxifloxacin + DAV132 | DAV132 (7.5g x3/day taken orally for 7 days) associated to Moxifloxacin (400mg x1/day taken orally for 5 days) | 0 | 14 | 0 | 14 | 10 | 14 |
| EG002 | DAV132 | DAV132 (7.5g x3/day taken orally for 7 days) used alone | 0 | 8 | 0 | 8 | 2 | 8 |
| EG003 | Negative Control | Negative control: microcrystalline cellulose (7.5g x3/day taken orally for 7 days) | 0 | 8 | 0 | 8 | 1 | 8 |
| Diarrhoea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Intestinal transit time abnormal | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Formication | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Reproductive system and breast disorders | MedDRA (17.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |