Status:
COMPLETED
VA106483 Dose Response in Females
Lead Sponsor:
Vantia Ltd
Conditions:
Nocturia
Eligibility:
FEMALE
40+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to describe the pharmacokinetics and pharmacodynamics of VA106483 in female subjects.
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 voi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT01171391
Start Date
July 1 2010
End Date
November 1 2010
Last Update
December 1 2010
Active Locations (1)
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1
Quintiles Phase I Services
Overland Park, Kansas, United States, 66211