NCT01171391

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

July 19, 2010

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 28, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

December 1, 2010

Status Verified

November 1, 2010

Enrollment Period

4 months

First QC Date

July 19, 2010

Last Update Submit

November 30, 2010

Conditions

Nocturia

Keywords

NocturiaPharmacokineticsPharmacodynamicsWater-loadingFemales

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetics

    VA106483 plasma concentration pre-dose over a 24hr post-dose period to assess pharmacokinetics of each dose level

    10 days

Secondary Outcomes (2)

  • Pharmacodynamics

    10 days

  • Safety and Tolerability

    10 days

Study Arms (4)

VA106483 1mg

EXPERIMENTAL
Drug: VA106483

VA106483 2mg

EXPERIMENTAL
Drug: VA106483

VA106483 4mg

EXPERIMENTAL
Drug: VA106483

Sugar pill

PLACEBO COMPARATOR
Other: Placebo

Interventions

VA106483DRUG

1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7

VA106483 1mgVA106483 2mgVA106483 4mg
PlaceboOTHER

Placebo on Day 1

Sugar pill

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Quintiles Phase I Services

Overland Park, Kansas, 66211, United States

Location

MeSH Terms

Conditions

Nocturia

Condition Hierarchy (Ancestors)

Lower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ralph Schutz

    Quintiles Phase I Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 19, 2010

First Posted

July 28, 2010

Study Start

July 1, 2010

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

December 1, 2010

Record last verified: 2010-11

Locations

US(1)