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VA106483 Dose Response in Females

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01171391
First Posted: July 28, 2010
Last Update Posted: December 1, 2010
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.
Information provided by:
Vantia Ltd
  Purpose
The purpose of this study is to describe the pharmacokinetics and pharmacodynamics of VA106483 in female subjects.

Condition Intervention Phase
Nocturia Drug: VA106483 Other: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Label, Dose Escalation Study to Assess Intra-Subject Dose Response to VA106483 in Female Subjects

Further study details as provided by Vantia Ltd:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 10 days ]
    VA106483 plasma concentration pre-dose over a 24hr post-dose period to assess pharmacokinetics of each dose level


Secondary Outcome Measures:
  • Pharmacodynamics [ Time Frame: 10 days ]
    Urine volume and osmolality

  • Safety and Tolerability [ Time Frame: 10 days ]
    AEs, laboratory safety tests, vital signs and ECG, physical examination.


Enrollment: 21
Study Start Date: July 2010
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: VA106483 1mg Drug: VA106483
1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
Experimental: VA106483 2mg Drug: VA106483
1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
Experimental: VA106483 4mg Drug: VA106483
1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
Placebo Comparator: Sugar pill Other: Placebo
Placebo on Day 1

Detailed Description:

Nocturia, defined as waking to void at least once per night between periods of sleep, is a common complaint and shows an age-dependent increase in both prevalence and severity (number of nocturnal voids). The most common causes are detrusor over-activity, reduced nighttime functional bladder capacity, and nocturnal polyuria.

VA106483 is a selective vasopressin V2-receptor agonist in development for nocturia. VA106483 is a non-peptide drug that displays much improved oral availability over desmopressin and low dependence on glomerular filtration for its elimination.

VA106483 has been administered to 184 subjects (including healthy adult subjects [males and females], children [males and females] with nocturia and 48 elderly males [aged 65 years and over]). It has been administered as single doses both intravenously, up to doses of approximately 250 mg and orally up to 50 mg It is also being investigated in approximately 123 male subjects (two-thirds on active medication, one third on placebo) with nocturia in a current study with dosing for up to 8 weeks.

This intra-subject dose escalation study has previously been conducted in 10 elderly male subjects to determine whether subjects demonstrated a dose-dependent pharmacokinetic and pharmacodynamic (urine osmolality and diuresis) response and whether the dose of VA106483 could be titrated within an individual patient to achieve optimal clinical response in clinical practice. Given that to date, only 8 females have been exposed to VA106483, the purpose of this study is to confirm that the described duration of pharmacokinetics and pharmacodynamics of VA106483 in males is similar in females.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female subjects 40 years and above
  • BMI 18 to 32 kg/m2
  • Using adequate contraception and providing negative pregnancy tests pre-dose
  • In good health as determined by medical history and screening tests
  • Subject is willing and able to abstain from alcohol and caffeine-containing food and beverages 72 hours prior to dosing and throughout the study
  • Provide written, informed consent

Exclusion Criteria:

  • Pregnancy or lactation
  • Evidence of serious pathology or diseases including heart, hormone, liver and kidney, psychiatric and neurological problems, including syndrome of inappropriate antidiuretic hormone secretion, polydipsia or diabetes insipidus
  • Likely to be hypersensitive to VA106483
  • History of any relevant allergy
  • Participation in a clinical study within 30 days
  • Donation of blood (500 mL) within 60 days prior to dosing
  • A history of alcohol abuse or drug addiction
  • Positive results for HIV, HBV or HCV or drugs of abuse
  • Currently taking any diuretics or clinically significant cytochrome 3A4 inhibitors or inducers
  • Use of any non-prescription preparation within 72 hours prior to dosing, with the exception of ibuprofen, and acetaminophen used at recommended doses
  • Treatment within the previous 3 months of drugs known to have a well defined potential for hepatoxicity
  • Current smokers or recent ex-smokers
  • Other protocol defined eligibility criteria may apply
  Contacts and Locations
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): NCT01171391


Locations
United States, Kansas
Quintiles Phase I Services
Overland Park, Kansas, United States, 66211
Sponsors and Collaborators
Vantia Ltd
Investigators
Principal Investigator: Ralph Schutz Quintiles Phase I Services
  More Information

Responsible Party: Chief Medical Officer, Vantia Ltd
ClinicalTrials.gov Identifier: NCT01171391     History of Changes
Other Study ID Numbers: 483-007
First Submitted: July 19, 2010
First Posted: July 28, 2010
Last Update Posted: December 1, 2010
Last Verified: November 2010

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

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