Safety and Efficacy Study of Different DAV132 Dose Regimens in Healthy Volunteers
NCT ID: NCT02917200
Last Updated: 2017-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
150 participants
INTERVENTIONAL
2016-05-11
2016-12-02
Brief Summary
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Detailed Description
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* 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
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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MOX + CTRL
Moxifloxacin, 400 mg/day oad, 5 days + Negative control, tid, 7 days
Moxifloxacin
Oral route
Negative control
Oral route
MOX + DAV132 7.5 g tid
Moxifloxacin, 400 mg/day oad, 5 days + DAV132 7.5 g tid, 7 days
Moxifloxacin
Oral route
DAV132
Oral route
MOX + DAV132 7.5 g bid
Moxifloxacin, 400 mg/day oad, 5 days + DAV132 7.5 g bid, 7 days
Moxifloxacin
Oral route
DAV132
Oral route
MOX + DAV132 5 g tid
Moxifloxacin, 400 mg/day oad, 5 days + DAV132 5 g tid, 7 days
Moxifloxacin
Oral route
DAV132
Oral route
MOX + DAV132 5 g bid
Moxifloxacin, 400 mg/day oad, 5 days + DAV132 5 g bid, 7 days
Moxifloxacin
Oral route
DAV132
Oral route
MOX + DAV132 3.3 g tid
Moxifloxacin, 400 mg/day oad, 5 days + DAV132 3.3 g tid, 7 days
Moxifloxacin
Oral route
DAV132
Oral route
MOX + DAV132 3 g bid
Moxifloxacin, 400 mg/day oad, 5 days + DAV132 3 g bid, 7 days
Moxifloxacin
Oral route
DAV132
Oral route
MOX + DAV132 2 g tid
Moxifloxacin, 400 mg/day oad, 5 days + DAV132 2 g tid, 7 days
Moxifloxacin
Oral route
DAV132
Oral route
MOX + DAV132 1.5 g bid
Moxifloxacin, 400 mg/day oad, 5 days + DAV132 1.5 g bid, 7 days
Moxifloxacin
Oral route
DAV132
Oral route
MOX + DAV132 1 g tid
Moxifloxacin, 400 mg/day oad, 5 days + DAV132 1 g tid, 7 days
Moxifloxacin
Oral route
DAV132
Oral route
MOX + DAV132 1 g bid
Moxifloxacin, 400 mg/day oad, 5 days + DAV132 1 g bid, 7 days
Moxifloxacin
Oral route
DAV132
Oral route
CTRL
Negative control, tid, 7 days
Negative control
Oral route
Interventions
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Moxifloxacin
Oral route
DAV132
Oral route
Negative control
Oral route
Eligibility Criteria
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Inclusion Criteria
2. Body mass index (BMI) 18.5 - 30 kg/m² inclusive.
3. Considered as healthy individuals according to a comprehensive clinical assessment (detailed medical history and full physical examination).
4. 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.
5. 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.
6. 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.
7. Normal digestive transit, with at least one daily stool.
8. 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.
9. Having given and signed the written study informed consent prior to undertake any study-related procedure.
10. Covered by the French health insurance system.
Exclusion Criteria
1. 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.
2. Any history of relevant gastrointestinal disorders within three months prior to inclusion.
3. 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.
4. Presence or history of drug hypersensitivity, or allergic disease diagnosed and treated by a physician.
Criteria specific to the study
7. Fecal colonization by C. difficile.
8. Recent history of hospitalization (within the last 3 months).
9. Any antibiotic administration within the last 3 months.
10. Any vaccination within the last 28 days.
11. Blood donation, regardless of the volume, within 2 months before inclusion and during the study.
12. 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
13. History or presence of drug or alcohol abuse (alcohol consumption more than 40 g per day).
14. 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.
15. Excessive consumption of beverages containing xanthine bases (more than 4 cups or glasses per day).
16. Positive result on urine drug screen (amphetamines / methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
17. Positive alcohol test. Administrative criteria
18. 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.
19. Any subject in the exclusion period of a previous biomedical research according to national law, and participation to any other clinical trial simultaneously.
20. Any subject who cannot be contacted in case of emergency.
21. Any subject who belongs to the Investigating Center staff.
22. Subject of legal age unable to give consent
23. Subject deprived of liberty by judicial or administrative decision
24. Subject of legal age under legal protection.
18 Years
60 Years
ALL
Yes
Sponsors
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Da Volterra
INDUSTRY
Responsible Party
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Principal Investigators
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Yves Donazzolo
Role: PRINCIPAL_INVESTIGATOR
Eurofins Optimed
Locations
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Eurofins Optimed
Gières, , France
Countries
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Other Identifiers
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2015-A01899-40
Identifier Type: REGISTRY
Identifier Source: secondary_id
DAV132-CL-1004
Identifier Type: -
Identifier Source: org_study_id
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