Healthy SubjectsPhase 1NCT02917200
Safety and Efficacy Study of Different DAV132 Dose Regimens in Healthy Volunteers
A Phase 1 study testing Moxifloxacin and DAV132 in people with Healthy Subjects, run by Da Volterra at 1 site in France.
Trial summary
The purpose of this study is to evaluate whether different DAV132 dose regimens are safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Moxifloxacin and DAV132
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2016to 2 Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy adults (males and females), able to read and write, aged from 18 to 60 years old inclusive.
- Body mass index (BMI) 18.5 - 30 kg/m² inclusive.
- Considered as healthy individuals according to a comprehensive clinical assessment (detailed medical history and full physical examination).
- Normal vital signs after 10-min rest in supine position: systolic blood pressure 95 - 140 mmHg inclusive, diastolic blood pressure 45 - 90 mmHg inclusive and heart rate (pulse rate) 50 - 100 bpm inclusive. Out of range values can be accepted if judged clinically non relevant by the Investigator.
- Normal 12-lead ECG after 10-min rest in supine position: PR interval 120 - 220 msec exclusive, QRS complex <120 msec, and QT interval <430 msec if male or <450 msec if female.
- Normal hematology and blood biochemistry test results. Out of range values can be accepted if judged clinically non relevant by the Investigator excepted for potassium and magnesium for which normal values are required.
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- Normal digestive transit, with at least one daily stool.
- Females participating in the study:
- either must be of non-child bearing potential (surgically sterilized at least 3 months prior to inclusion, or postmenopausal). Menopause is defined as being over 60 years of age, or between 45 and 60 years of age and being amenorrheic for at least 2 years with plasma FSH levels >30 IU/L;
- or must have a negative pregnancy test and be not breastfeeding at screening, and must use abstinence or a double contraception method during the treatment period and for an additional period of 2 weeks after the end of investigational treatment. The accepted double contraception methods include the use of a highly effective method of birth control (intrauterine device or hormonal contraception) in addition to one of the following contraceptive options: (1) condom, (2) diaphragm or cervical/vault cap, (3) spermicide.
- Having given and signed the written study informed consent prior to undertake any study-related procedure.
- Covered by the French health insurance system.
Who cannot join
- Criteria related to the healthy status
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, bone and joint, muscular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease; or signs of acute illness.
- Any history of relevant gastrointestinal disorders within three months prior to inclusion.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for each event, more than twice a month). Subject suffering from migraine on D1 will be excluded.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
- Criteria specific to the study
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- Contraindications to fluoroquinolones, or risk factors for adverse effects associated to fluoroquinolones as defined in the moxifloxacin Summary of Product Characteristics, and other than those already included into the inclusion/exclusion criteria: known hypersensitivity to fluoroquinolones, history of tendinopathy associated with fluoroquinolones, risk factor for tendinopathy / known tendon disorder, pregnancy, breast feeding, known history of myasthenia gravis, known history of / risk factors for QT interval prolongation (including close family history of arrhythmic disorders). Subjects with a family history of, or actual glucose-6-phosphate dehydrogenase (G6PDH) deficiency should be excluded. Subjects with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should be excluded.
- Contraindications to charcoal, or risk factors for adverse events associated to charcoal other than those already included into the inclusion/exclusion criteria: known hypersensitivity to charcoal, risk of gastrointestinal obstruction, perforation or hemorrhage, recent digestive tract surgery.
- Fecal colonization by C. difficile.
- Recent history of hospitalization (within the last 3 months).
- Any antibiotic administration within the last 3 months.
- Any vaccination within the last 28 days.
- Blood donation, regardless of the volume, within 2 months before inclusion and during the study.
- Any previous administration of medication and any previous intake of herbal products known to interfere with drug metabolism such as St John's Wort within the last 14 days, with the exception of hormonal contraception or menopausal hormone replacement therapy or paracetamol.
- Criteria associated with addiction
- History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day).
- Smoking more than 5 cigarettes or equivalent per day (including nicotine-delivering devices such as patches, gums and electronic cigarettes), unable to stop smoking during the study.
- Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
- Positive result on urine drug screen (amphetamines / methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- Positive alcohol test. Administrative criteria
- Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.
- Any subject in the exclusion period of a previous biomedical research according to national law, and participation to any other clinical trial simultaneously.
- Any subject who cannot be contacted in case of emergency.
- Any subject who belongs to the Investigating Center staff.
- Subject of legal age unable to give consent
- Subject deprived of liberty by judicial or administrative decision
- Subject of legal age under legal protection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Different DAV132 Dose Regimens (From 2 to 22.5 g/Day During 7 Days, Bid and Tid) on the Fecal Moxifloxacin Concentrations and the Intestinal Microbiota of Healthy Volunteers Treated With Moxifloxacin 400 mg/Day During 5 Days
The purpose of this study is to evaluate whether different DAV132 dose regimens are safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.
Read the detailed description
The aim of the study is to evaluate the performances of different DAV132 dose regimens in healthy volunteers:
- To capture antibiotic residues in the colon without interfering with its systemic pharmacokinetics.
- To prevent antibiotic-induced changes of the intestinal microbiota. In addition, the security of DAV132 given at different dose regimens during 7 days will be evaluated.
This is a prospective, randomized, controlled, repeated doses, 12 parallel groups, open-label study, blinded to analytical and microbiological evaluations.
- Conditions
- Healthy Subjects
- Being tested
- Moxifloxacin, DAV132, Negative control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MoxifloxacinDrug
Oral route
DAV132Device
Oral route
Negative controlOther
Oral route
| Study group | Role | What they receive |
|---|---|---|
| MOX + CTRL | Active comparator | Moxifloxacin, 400 mg/day oad, 5 days + Negative control, tid, 7 days Receives: Drug: Moxifloxacin; Other: Negative control |
| MOX + DAV132 7.5 g tid | Experimental | Moxifloxacin, 400 mg/day oad, 5 days + DAV132 7.5 g tid, 7 days Receives: Drug: Moxifloxacin; Device: DAV132 |
| MOX + DAV132 7.5 g bid | Experimental | Moxifloxacin, 400 mg/day oad, 5 days + DAV132 7.5 g bid, 7 days Receives: Drug: Moxifloxacin; Device: DAV132 |
| MOX + DAV132 5 g tid | Experimental | Moxifloxacin, 400 mg/day oad, 5 days + DAV132 5 g tid, 7 days Receives: Drug: Moxifloxacin; Device: DAV132 |
| MOX + DAV132 5 g bid | Experimental | Moxifloxacin, 400 mg/day oad, 5 days + DAV132 5 g bid, 7 days Receives: Drug: Moxifloxacin; Device: DAV132 |
| MOX + DAV132 3.3 g tid | Experimental | Moxifloxacin, 400 mg/day oad, 5 days + DAV132 3.3 g tid, 7 days Receives: Drug: Moxifloxacin; Device: DAV132 |
| MOX + DAV132 3 g bid | Experimental | Moxifloxacin, 400 mg/day oad, 5 days + DAV132 3 g bid, 7 days Receives: Drug: Moxifloxacin; Device: DAV132 |
| MOX + DAV132 2 g tid | Experimental | Moxifloxacin, 400 mg/day oad, 5 days + DAV132 2 g tid, 7 days Receives: Drug: Moxifloxacin; Device: DAV132 |
| MOX + DAV132 1.5 g bid | Experimental | Moxifloxacin, 400 mg/day oad, 5 days + DAV132 1.5 g bid, 7 days Receives: Drug: Moxifloxacin; Device: DAV132 |
| MOX + DAV132 1 g tid | Experimental | Moxifloxacin, 400 mg/day oad, 5 days + DAV132 1 g tid, 7 days Receives: Drug: Moxifloxacin; Device: DAV132 |
| MOX + DAV132 1 g bid | Experimental | Moxifloxacin, 400 mg/day oad, 5 days + DAV132 1 g bid, 7 days Receives: Drug: Moxifloxacin; Device: DAV132 |
| CTRL | Other | Negative control, tid, 7 days Receives: Other: Negative control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve of free moxifloxacin fecal concentrations from D1 to D16 (AUC D1-D16)
Measured: over 16 days after treatment start
Secondary outcomes (6)
Bacterial diversity of the intestinal microbiota (16S rDNA profiling)
Measured: over 37 days after treatment start
Area under the curve of moxifloxacin plasma concentrations from 0 to 24 hours (AUC0-24h) on D1 and D5
Measured: over 5 days after treatment start
Maximum moxifloxacin plasma concentrations (Cmax) on D1 and D5
Measured: over 5 days after treatment start
Number of adverse events and percentage of subjects with at least one adverse event
Measured: over 37 days after treatment start
Number of subjects with samples positive for treatment-emergent quinolone / fluoroquinolone-resistant Enterobacteriaceae
Measured: over 37 days after treatment start
Occurrence of Clostridium difficile infection, evaluated by identification of C. difficile in diarrheic stools
Measured: over 37 days after treatment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2016 (estimated)
- Study start11 May 2016
- Primary completion2 Dec 2016
- Study completion2 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Da Volterra
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yves Donazzolo, Principal investigator, Eurofins Optimed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02917200
- Sponsor's protocol ID
- DAV132-CL-1004
- Other IDs
- 2015-A01899-40
- Status last verified
- Sep 2017
- First submitted
- 19 Sep 2016
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Different DAV132 Dose Regimens (From 2 to 22.5 g/Day During 7 Days, Bid and Tid) on the Fecal Moxifloxacin Concentrations and the Intestinal Microbiota of Healthy Volunteers Treated With Moxifloxacin 400 mg/Day During 5 Days
- ClinicalTrials.gov ID
- NCT02917200
- Acronym / sponsor ID
- DAV132-CL-1004
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Da VolterraIndustry (pharma, biotech, devices)
- Study start
- 11 May 2016 (actual)
- Primary completion
- 2 Dec 2016 (actual)
- Study completion
- 2 Dec 2016 (actual)
- First posted
- 28 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether different DAV132 dose regimens are safe and effective for capturing fecal residues of moxifloxacin in healthy volunteers.
Detailed description
The aim of the study is to evaluate the performances of different DAV132 dose regimens in healthy volunteers:
- To capture antibiotic residues in the colon without interfering with its systemic pharmacokinetics.
- To prevent antibiotic-induced changes of the intestinal microbiota. In addition, the security of DAV132 given at different dose regimens during 7 days will be evaluated.
This is a prospective, randomized, controlled, repeated doses, 12 parallel groups, open-label study, blinded to analytical and microbiological evaluations.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| MOX + CTRL | Active comparator | Drug: Moxifloxacin, Other: Negative controlMoxifloxacin, 400 mg/day oad, 5 days + Negative control, tid, 7 days |
| MOX + DAV132 7.5 g tid | Experimental | Drug: Moxifloxacin, Device: DAV132Moxifloxacin, 400 mg/day oad, 5 days + DAV132 7.5 g tid, 7 days |
| MOX + DAV132 7.5 g bid | Experimental | Drug: Moxifloxacin, Device: DAV132Moxifloxacin, 400 mg/day oad, 5 days + DAV132 7.5 g bid, 7 days |
| MOX + DAV132 5 g tid | Experimental | Drug: Moxifloxacin, Device: DAV132Moxifloxacin, 400 mg/day oad, 5 days + DAV132 5 g tid, 7 days |
| MOX + DAV132 5 g bid | Experimental | Drug: Moxifloxacin, Device: DAV132Moxifloxacin, 400 mg/day oad, 5 days + DAV132 5 g bid, 7 days |
| MOX + DAV132 3.3 g tid | Experimental | Drug: Moxifloxacin, Device: DAV132Moxifloxacin, 400 mg/day oad, 5 days + DAV132 3.3 g tid, 7 days |
| MOX + DAV132 3 g bid | Experimental | Drug: Moxifloxacin, Device: DAV132Moxifloxacin, 400 mg/day oad, 5 days + DAV132 3 g bid, 7 days |
| MOX + DAV132 2 g tid | Experimental | Drug: Moxifloxacin, Device: DAV132Moxifloxacin, 400 mg/day oad, 5 days + DAV132 2 g tid, 7 days |
| MOX + DAV132 1.5 g bid | Experimental | Drug: Moxifloxacin, Device: DAV132Moxifloxacin, 400 mg/day oad, 5 days + DAV132 1.5 g bid, 7 days |
| MOX + DAV132 1 g tid | Experimental | Drug: Moxifloxacin, Device: DAV132Moxifloxacin, 400 mg/day oad, 5 days + DAV132 1 g tid, 7 days |
| MOX + DAV132 1 g bid | Experimental | Drug: Moxifloxacin, Device: DAV132Moxifloxacin, 400 mg/day oad, 5 days + DAV132 1 g bid, 7 days |
| CTRL | Other | Other: Negative controlNegative control, tid, 7 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Healthy adults (males and females), able to read and write, aged from 18 to 60 years old inclusive.
- Body mass index (BMI) 18.5 - 30 kg/m² inclusive.
- Considered as healthy individuals according to a comprehensive clinical assessment (detailed medical history and full physical examination).
- Normal vital signs after 10-min rest in supine position: systolic blood pressure 95 - 140 mmHg inclusive, diastolic blood pressure 45 - 90 mmHg inclusive and heart rate (pulse rate) 50 - 100 bpm inclusive. Out of range values can be accepted if judged clinically non relevant by the Investigator.
- Normal 12-lead ECG after 10-min rest in supine position: PR interval 120 - 220 msec exclusive, QRS complex <120 msec, and QT interval <430 msec if male or <450 msec if female.
Key exclusion criteria (27 listed)
- Criteria related to the healthy status
- Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, bone and joint, muscular, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease; or signs of acute illness.
- Any history of relevant gastrointestinal disorders within three months prior to inclusion.
- Frequent headaches and/or migraine, recurrent nausea and/or vomiting (for each event, more than twice a month). Subject suffering from migraine on D1 will be excluded.
- Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MoxifloxacinOral route | Drug | MOX + CTRL, MOX + DAV132 1 g bid, MOX + DAV132 1 g tid, MOX + DAV132 1.5 g bid, MOX + DAV132 2 g tid, MOX + DAV132 3 g bid, MOX + DAV132 3.3 g tid, MOX + DAV132 5 g bid, MOX + DAV132 5 g tid, MOX + DAV132 7.5 g bid, MOX + DAV132 7.5 g tid |
| DAV132Oral route | Device | MOX + DAV132 1 g bid, MOX + DAV132 1 g tid, MOX + DAV132 1.5 g bid, MOX + DAV132 2 g tid, MOX + DAV132 3 g bid, MOX + DAV132 3.3 g tid, MOX + DAV132 5 g bid, MOX + DAV132 5 g tid, MOX + DAV132 7.5 g bid, MOX + DAV132 7.5 g tid |
| Negative controlOral route | Other | CTRL, MOX + CTRL |
Primary outcome
Area under the curve of free moxifloxacin fecal concentrations from D1 to D16 (AUC D1-D16)
Time frame: over 16 days after treatment start
6 secondary outcomes
Bacterial diversity of the intestinal microbiota (16S rDNA profiling)
Time frame: over 37 days after treatment start
Area under the curve of moxifloxacin plasma concentrations from 0 to 24 hours (AUC0-24h) on D1 and D5
Time frame: over 5 days after treatment start
Maximum moxifloxacin plasma concentrations (Cmax) on D1 and D5
Time frame: over 5 days after treatment start
Number of adverse events and percentage of subjects with at least one adverse event
Time frame: over 37 days after treatment start
Number of subjects with samples positive for treatment-emergent quinolone / fluoroquinolone-resistant Enterobacteriaceae
Time frame: over 37 days after treatment start
Occurrence of Clostridium difficile infection, evaluated by identification of C. difficile in diarrheic stools
Time frame: over 37 days after treatment start
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yves Donazzolo principal investigator
Eurofins Optimed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Moxifloxacin and DAV132 in people with Healthy Subjects, run by Da Volterra at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the curve of free moxifloxacin fecal concentrations from D1 to D16 (AUC D1-D16) (time frame: over 16 days after treatment start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2017.