Status:
COMPLETED
VA106483 Dose Response Study in Elderly Males
Lead Sponsor:
Vantia Ltd
Conditions:
Nocturia
Eligibility:
MALE
65+ years
Phase:
PHASE1
Brief Summary
The main purpose of the study is to evaluate the way VA106483 enters and leaves the blood and tissues over time and how the drug acts on and in the body at various dose levels compared to placebo in t...
Detailed Description
VA106483 is intended to be used as a treatment for patients suffering from nocturia (defined as waking to urinate at least once per night between periods of sleep). Nocturia is a condition that often ...
Eligibility Criteria
Inclusion
- Male, Age: 65 years and above
- Using adequate contraception
- Medical history without clinically significant pathologies; no evidence of serious pathology or disease
- Physical examination parameters without signs of serious disease
- No clinically significant ECG and lab safety tests (sodium must be within normal range)
- Willing and able to participate and provides written informed consent
Exclusion
- Cardiac insufficiency; signs or symptoms suggestive of heart failure or requiring treatment with diuretics
- Supine arterial blood pressure higher than 170/100 mmHg or less than 105/60 mm Hg
- Presence of poorly controlled endocrine disorders
- Renal insufficiency, active hepatic and/or biliary disease
- Hyponatraemia. Serum sodium level must be within normal limits
- Syndrome of inappropriate antidiuretic hormone (ADH) secretion
- Symptoms suggestive of psychogenic or habitual polydipsia or of diabetes insipidus
- Known hypersensitivity to the IP or any constituent of the IP
- Use of any non-prescription preparation within 72 hours prior to study entry, with the exception of defined pain killers
- A history of alcohol abuse or drug addiction within the last 2 years
- Positive screen for HIV, hepatitis B or C
- Currently taking any diuretics or any concomitant medication known to be a cytochrome 3A4 inhibitor
- Other protocol defined eligibility criteria may apply.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00922740
Start Date
June 1 2009
End Date
September 1 2009
Last Update
May 23 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Quintiles Phase I Services
Overland Park, Kansas, United States, 66211