VA106483 and Alpha Blocker Interaction Study in Elderly Males

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

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.

Study Overview

• Status: Completed
• Conditions: Nocturia
• Intervention / Treatment: Drug: Placebo; Drug: VA106483

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 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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Edinburgh, United Kingdom, EH12 1DF
    • Charles River Clinical Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Vantia Ltd
• Investigators: Study Director: Medical Director, Charles River Clinical Services, Edinburgh, UK

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: April 8, 2009
• First Submitted That Met QC Criteria: April 8, 2009
• First Posted (Estimate): April 9, 2009

Study Record Updates

• Last Update Posted (Estimate): November 25, 2009
• Last Update Submitted That Met QC Criteria: November 24, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Elderly; Nocturia; Males; Hyptotension
• Additional Relevant MeSH Terms: Lower Urinary Tract Symptoms; Urological Manifestations; Nocturia
• Other Study ID Numbers: 483-003