VA106483 Dose Response Study in Elderly Males

This study has been completed.
Sponsor:
Information provided by:
Vantia Ltd
ClinicalTrials.gov Identifier:
NCT00922740
First received: June 10, 2009
Last updated: November 24, 2009
Last verified: November 2009
  Purpose

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 Intervention Phase
Nocturia
Drug: VA106483
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Escalation Study to Assess Intra-Subject Dose Response to VA106483 in Elderly Male Subjects

Further study details as provided by Vantia Ltd:

Primary Outcome Measures:
  • Urine volume and osmolality and plasma PK assessments [ Time Frame: 24 Hours ] [ Designated as safety issue: No ]

Enrollment: 10
Study Start Date: June 2009
Study Completion Date: September 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: June 10, 2009
Last Updated: November 24, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 15, 2014