ClinicalTrials.gov
ClinicalTrials.gov Menu

VA106483 Dose Response Study in Elderly Males

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00922740
Recruitment Status : Completed
First Posted : June 17, 2009
Last Update Posted : November 25, 2009
Sponsor:
Information provided by:
Vantia Ltd

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 the same volunteer.

Condition or disease Intervention/treatment Phase
Nocturia Drug: VA106483 Drug: Placebo Phase 1

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.

The only antidiuretic approved for the treatment (in some countries) of nocturia is the peptide drug, desmopressin. However, as it can cause hyponatraemia in a proportion of patients above the age of 65 years it is contra-indicated in the elderly. This side-effect has not been observed with VA106483, making it potentially suitable for treating the elderly. The purpose of this study is to confirm that duration of action of VA106483 can be effectively controlled by dose and therefore that satisfactory clinical outcome in the treatment of nocturia can be achieved by individual dose titration.

Subjects will be water-loaded, dosed with either VA106483 or placebo and then urine production will be monitored to assess any anti-diuretic effect.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Escalation Study to Assess Intra-Subject Dose Response to VA106483 in Elderly Male Subjects
Study Start Date : June 2009
Actual Primary Completion Date : July 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: VA106483 1 mg, 2 mg, 4 mg Drug: VA106483
Placebo on Day 1, 1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
Placebo Comparator: Sugar pill Drug: Placebo
Placebo on Day 1, 1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7



Primary Outcome Measures :
  1. Urine volume and osmolality and plasma PK assessments [ Time Frame: 24 Hours ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00922740


Locations
United States, Kansas
Quintiles Phase I Services
Overland Park, Kansas, United States
Sponsors and Collaborators
Vantia Ltd
Investigators
Principal Investigator: Ralph Schutz Quintiles Phase I Services, Overland Park, KS

Responsible Party: Ralph Schutz, MD / Senior Medical Services Director, Quintiles Phase I Services, Overland Park, KS
ClinicalTrials.gov Identifier: NCT00922740     History of Changes
Other Study ID Numbers: 483-002
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: November 25, 2009
Last Verified: November 2009

Keywords provided by Vantia Ltd:
Nocturia
Pharmacokinetics
Pharmacodynamics
Water-loading
Elderly
Males

Additional relevant MeSH terms:
Nocturia
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms