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 the same volunteer.
We will connect you to the doctor responsible for this trial and help you get more information.
Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT00922740
Ages eligible for Study
65 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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.
All locations for NCT00922740
United States (1)
Quintiles Phase I Services
Overland Park, Kansas, United States, 66211
View full eligibility
Tris trial is registered with FDA with number: NCT00922740. The sponsor of the trial is Vantia Ltd and it is looking for 10 volunteers for the current phase.
Official trial title: An Open Label, Escalation Study to Assess Intra-Subject Dose Response to VA106483 in Elderly Male Subjects
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