VA106483 Dose Response in Females

Completed · Phase 1 · Has a placebo group

Conditions studied: Nocturia

In brief

The purpose of this study is to describe the pharmacokinetics and pharmacodynamics of VA106483 in female subjects.

Key facts

Study ID

NCT01171391

Run by

Vantia Ltd

People needed

21

Starts

2010-07-01

Expected to finish

2010-11-01

Last updated by the study team

2010-12-01

Who can join

Age: 40 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Quintiles Phase I Services — Overland Park, Kansas, United States

Full record on ClinicalTrials.gov

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