VA106483 and Alpha Blocker Interaction Study in Elderly Males

Study Overview
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Brief Summary
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The main purpose of this study is to investigate whether the hypotensive effects of an alpha-blocker are increased when VA106483 is given at the same time.

Detailed Description
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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 worsens as sufferers get older. This may be due to an over-active bladder muscle, the bladder being able to hold less urine at night-time or over production of urine in the bladder at night. Some of the treatments available for nocturia have side-effects which make them unsuitable for elderly patients. These side-effects have not been seen in studies with VA106483, which makes it potentially suitable for treating elderly patients. Nocturia is commonly associated with Benign Prostatic Hypertrophy (or BPH, a non-cancerous enlargement of the prostate gland, which often results in problems passing water). Of the patients who suffer from BPH, an estimated 40-85% experience the symptoms of waking at night to pass water. Treatments which are commonly prescribed for BPH include alpha-blockers which work by improving urine flow by a muscle relaxant effect. Alpha-blockers are known to cause hypotension (lowering of blood pressure which can cause dizziness in some patients) . Since it is likely that subjects may be co-prescribed VA106483 and alpha-blockers, the purpose of this study is to determine that giving VA106483 does not increase the hypotensive effects of alpha-blockers

Official Title
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A Single Centre, Double-blind, Placebo Controlled Crossover Study in Elderly Male Subjects to Investigate the Plarmacodynamic Interaction of VA106483 Administered Concomitanctly With Alpha-blocker Therapy

Conditions
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Nocturia

Intervention / Treatment
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* Drug: VA106483
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male aged 65 years of age and above No clinically important abnormal physical, laboratory or vital sign findings in the opinion of the Investigator Provision of written informed consent to participate No recent alpha-blocker therapy Not taking any concomitant medication known to be a cytochrome 3A4 inhibitor Not taking any prescribed or over the counter medications unless agreed with the Investigator and Sponsor No evidence of serious pathology or disease including poorly controlled endocrine disorders; active liver or biliary disease or severe kidney problems; syndrome of inappropriate antidiuretic hormone secretion No history of orthostatic hypotension or syncope. No known hypersensitivity to the IMP or alpha blocker, including severe lactose intolerance. No history of drug or alcohol abuse Negative for HIV, hepatitis B or C

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Sugar pill<br> | Drug: Placebo<br>* 4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.<br>|
| Experimental: VA106483<br> | Drug: VA106483<br>* 4 mg orally on either Day 7 or 10 with the placebo crossover treatment on the alternate day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure, Heart rate |  | For 8 hours after dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyptotension, Elderly, Males, Nocturia