Bowel cleansing preparation Digestive System
Conditions
Interventions
According to the randomized cross-over design, the subjects will receive, in addition to the 8 Methylene Blue MMX® tablets, the AxMP according to a full dose regimen in one period and to a split-dose
Sponsors
Cosmo Technologies Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and age: men and women, 50-65 year old inclusive 3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive 4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position 5. Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the study 6. Fertility (women only): in post-menopausal status for at least 1 year
Exclusion criteria
Exclusion criteria: 1. Electrocardiogram (12-leads, supine position): clinically significant abnormalities 2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study 3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness 4. Allergy: ascertained or presumptive hypersensitivity to methylene blue and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study 5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine, psychiatric or neurological diseases that may interfere with the aim of the study and in particular asthma, anemia, deficiency of glucose-6-phosphate dehydrogenase and NADPH reductase or abnormal intestinal function, history of colorectal cancer or polyps; fecal occult blood positive patients 6. Medications: medications, including over the counter (OTC) medications and herbal remedies for 2 weeks before the start of the study. Concurrent or previous treatment, within 2 weeks before screening, with any of the prohibited psychiatric medications that may interact with methylene blue as listed in the drug safety alert published by the US FDA, which include selective serotonin reuptake inhibitors (SSRI), serotoninnorepinephrine reuptake inhibitors (SNRI), tricyclic anti-depressants or monoamine oxidase A inhibitors and other psychiatric drugs. Previous or concomitant treatment with fluoxetine within 5 weeks prior to screening, and/or previous or concomitant treatment with anticoagulants or antiaggregant agents inducing an international normalized ratio (INR) > 1.5 7. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study 8. Blood donation: blood donations for 3 months before this study 9. Drug, alcohol, caffeine, tobacco: history of drug, alcohol (>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015), caffeine (>5 cups coffee/tea/day) or tobacco abuse (=6 cigarettes/day) 10. Drug test: positive result at the abuse drug test at screening or day -1 11. Alcohol test: positive alcohol breath test at day -1 12. Diet: abnormal diets (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians 13. Pregnancy (females only): positive or missing pregnancy test at screening 14. Previous study of methylene blue: subject enrolled in a previous study of methylene blue
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic profile and kinetic parameters of methylene blue measured using a fully validated LC-MS/MS. The PK parameters were calculated at the following timepoints: post-dose starting from the intake of the last tablet at 4, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24, 36 h | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bowel cleansing quality evaluated according to the validated Boston Bowel Preparation Scale (BBPS) during a colonoscopy 2. Safety and tolerability of Methylene Blue MMX® modified-release tablets, assessed by evaluating treatment-emergent adverse events, vital signs, physical examinations, laboratory tests and ECG throughout the whole study | — |
Countries
Switzerland
Contacts
Public ContactNiall Donnelly
Outcome results
None listed