Nocturia. MedDRA version: 9.1 Level: LLT Classification code 10029446 Term: Nocturia
Conditions
Interventions
Product Code: VA106483
Pharmaceutical Form: Film-coated tablet
Current Sponsor code: VA106483
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form
Sponsors
Vantia Ltd
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Age: 65 years and above 2. Gender: Male 3. Weight: 55–95 kg 4. BMI: 18–32 kg/m2 5. Medical history without clinically relevant pathologies 6. A history of nocturia 7. Physical examination parameters without signs of serious disease 8. Electrocardiogram recording without signs of clinically relevant pathology, in particular QTc (Bazett) =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Female 2. Males aged under 65 years 3. Evidence of serious pathology or disease 4. Cardiac insufficiency; signs or symptoms suggestive of heart failure or requiring treatment with diuretics 5. Supine arterial blood pressure higher than 170/100 mmHg or less than 105/60 mmHg 6. Presence of poorly controlled endocrine disorders 7. Renal insufficiency. Subjects with impaired renal function defined as calculated creatinine clearance 10% above maximum of normal range. Total bilirubin should not be > 1.5 mg/dl (or equivalent). 9. Hyponatraemia. Plasma sodium level must be within normal limits 10. Syndrome of Inappropriate ADH secretion 11. Symptoms suggestive of psychogenic or habitual polydipsia or of diabetes insipidus 12. Mental handicap 13. Legal incapacity 14. Any history of clinically important emotional and/or psychiatric illness or of any clinically important neurological disorders and/or epilepsy 15. Chronic diarrhoea or other chronic gastrointestinal disorders 16. Known hypersensitivity to the study drug or constituent of the study drug 17. History of any relevant allergy, especially drug and/or food allergies 18. Strict vegetarian 19. Intake of diuretics 20. Intake of non-prescription medication or vitamin preparations within 14 days of drug administration 21. Use of St. John’s Wort or Ginkgo Biloba (also known as Ginkgo Bilbao) within 48 hours prior to randomization 22. Participation in a clinical study within 30 days prior to randomization 23. Donation of blood within 60 days prior to randomization 24. Receipt of blood, blood products or plasma derivates one year prior to randomization 25. Any history of alcohol abuse or drug addiction 26. Positive results at screen for drugs of abuse (cocaine, amphetamine / methamphetamine, tetrahydrocannabiol, opiates) or alcohol (breath test) at screening or on admission 27. Positive screen results for HBsAg, anti-HCV, or anti-HIV1&2 28. Any disease which in the Investigator’s opinion would exclude the subject from the study 29. Intake of any concomitant medication known to be a cytochrome 3A4 substrate or inhibitor with the exception of simvastatin, atorvastatin, lovastatin and cerivastatin* *The statins listed above are amongst the most common concomitant medications in the population under study. The highest exposure to VA106483 in the current study is Cmax of 71.1ng/ml at a dose of 4mg. Since the Ki of VA106483 for cytochrome P450 3A4 is 7500ng/ml the [I]/Ki is <0.01 rendering any interaction with other 3A4 substrates remote even at doses of VA106483 up to 16mg. Similarly, since the listed statins are also substrates, any effect on the pharmacokinetics of VA106483 is remote
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the pharmacodynamic profile of VA106483 including urinary volume, urinary osmolality, blood pressure, pulse rate, serum electrolytes and blood coagulation factors in elderly male subjects. To determine the pharmacokinetic profile of VA106483 in elderly male subjects. ;Secondary Objective: To assess the safety and tolerability of VA106483 given as single and repeated oral doses compared to placebo in elderly male subjects.;Primary end point(s): Pharmacokinetic parameters measured in plasma: AUC0-t, AUC0-8, AUC0-t, Cmax, Cmaxss, Ctrough, tmax, tmaxss, ?z, t½, MRT Pharmacodynamic parameters measured in plasma: Serum electrolytes sodium and potassium, hematocrit, serum osmolality, circulating FVIII and vWF levels Pharmacodynamic parameters measured in urine: Urinary volume and urine osmolality, AUC urine osmolality, total volume voided, urinary output rate, duration of antidiuretic action, number and frequency of nocturnal voids during non-water loading periods | — |
Countries
United Kingdom
Outcome results
None listed