VA106483 Dose Response Study in Elderly Males

Completed · Phase 1 · Has a placebo group

Conditions studied: Nocturia

In brief

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.

Key facts

Study ID

NCT00922740

Run by

Vantia Ltd

People needed

10

Starts

2009-06-01

Expected to finish

2009-09-01

Last updated by the study team

2018-05-23

Who can join

Age: 65 and older. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Quintiles Phase I Services — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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