Pharmacokinetic study in healthy male volunteers Not Applicable
Conditions
Interventions
All the subjects enrolled in the study receive the same treatment with the investigational medicinal product (IMP) as follows:
1. On Day 1, one dose of 3 g of fosfomycin (as fosfomycin
Sponsors
Zambon (Italy)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and age: men, 40-70 years old inclusive 3. Body Mass Index (BMI): 18.5-30 kg/m2 inclusive 4. Vital signs: systolic blood pressure (SBP) 100-139 mmHg, diastolic blood pressure (DBP) 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
Exclusion criteria
Exclusion criteria: 1. Electrocardiogram (ECG) 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 the active principle 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, genitourinary, skin, haematological, endocrine or neurological diseases that may interfere with the aim of the study 6. Medications: medications, including over the counter (OTC) medications and herbal remedies for 2 weeks before the screening visit 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 [>2 drinks/day, defined according to the USDA Dietary Guidelines 2015], caffeine (>5 cups coffee/tea/day) or tobacco abuse (=10 cigarettes/day) 10. Drug test: positive result at the 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fosfomycin concentrations and pharmacokinetics evaluated in plasma and urine using a fully validated liquid chromatography with tandem mass spectrometry (LC-MS-MS) method after one dose (Day 1) and two consecutive doses (Day 4) of the investigational medicinal product | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fosfomycin concentrations evaluated in prostate and seminal vesicles using a fully validated liquid chromatography with tandem mass spectrometry (LC-MS-MS) method after one dose (Day 1) and two consecutive doses (Day 4) of the investigational medicinal product 2. Safety and tolerability of the treatment evaluated by collecting the adverse events during the whole study and measuring vital signs (blood pressure and heart rate) at screening, on Days 1-2 and Days 4-5 and at the final visit. Safety and tolerability of the treatment are also evaluated by measuring the laboratory parameters, performing physical examinations including body weight and registering the ECG at screening and the final visit. | — |
Countries
Switzerland
Outcome results
None listed