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About
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.
Full description
The aim of the study is to evaluate the performances of different DAV132 dose regimens in healthy volunteers:
This is a prospective, randomized, controlled, repeated doses, 12 parallel groups, open-label study, blinded to analytical and microbiological evaluations.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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.
Normal digestive transit, with at least one daily stool.
Females participating in the study:
Having given and signed the written study informed consent prior to undertake any study-related procedure.
Covered by the French health insurance system.
Exclusion criteria
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
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.
Primary purpose
Allocation
Interventional model
Masking
150 participants in 12 patient groups
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Data sourced from clinicaltrials.gov
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