Nocturia Excessive night-time urination
Conditions
Interventions
The volunteer will receive 2 oral doses
one of 500 microgram and one of 4800
microgram FE 201836. In the third period the volunteer will receive a single
intravenous dose of 0.5 microgram.
Nocturia
Sponsors
Ferring Pharmaceuticals A/S
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. Signed written informed consent. 2. *65 years of age. 3. A body mass index (BMI) between 18.5-32.0 kg/m2 (both inclusive) and body weight between 50 kg and 110 kg. 4. Estimated GFR (eGFR) as assessed by the MDRD method *30 mL/min/1.73 m2.
Exclusion criteria
Exclusion criteria: 1. Presence or a history of clinically significant diseases of the hepatic, gastrointestinal, cardiovascular (including but not restricted to myocardial infarct, stroke, heart failure), or musculoskeletal system or presence or history of clinically significant immunological, endocrine, metabolic, or psychiatric (including schizophrenia in first grade relatives) diseases. 2. Presence of hyponatremia or serum sodium level 160mmHg and/or diastolic blood pressure >95 mmHg at the screening visit (confirmed by a second measurement). 4. Uncontrolled diabetes mellitus with a HbA1c>7.5% at the screening visit (confirmed by a second measurement)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Type, frequency and intensity of adverse events (AEs). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline of 12-lead electrocardiogram (ECG), blood pressure, clinical laboratory values, absorption and elimination of FE 201836. Pharmacodynamic parameters: Urine volume and urine concentration | — |
Countries
The Netherlands
Outcome results
None listed