Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
21 participants
INTERVENTIONAL
2010-07-31
2010-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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VA106483 1mg
VA106483
1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
VA106483 2mg
VA106483
1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
VA106483 4mg
VA106483
1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
Sugar pill
Placebo
Placebo on Day 1
Interventions
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VA106483
1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
Placebo
Placebo on Day 1
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
FEMALE
Yes
Sponsors
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Vantia Ltd
INDUSTRY
Responsible Party
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Vantia Ltd
Principal Investigators
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Ralph Schutz
Role: PRINCIPAL_INVESTIGATOR
Quintiles Phase I Services
Locations
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Quintiles Phase I Services
Overland Park, Kansas, United States
Countries
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Other Identifiers
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483-007
Identifier Type: -
Identifier Source: org_study_id