NCT00922740

Brief Summary

The main purpose of the study is to evaluate the way VA106483 enters and leaves the blood and tissues over time and how the drug acts on and in the body at various dose levels compared to placebo in the same volunteer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jun 2009

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

June 1, 2009

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

June 10, 2009

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 17, 2009

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

May 23, 2018

Status Verified

May 1, 2018

Enrollment Period

1 month

First QC Date

June 10, 2009

Last Update Submit

May 21, 2018

Conditions

Nocturia

Keywords

NocturiaPharmacokineticsPharmacodynamicsWater-loadingElderlyMales

Outcome Measures

Primary Outcomes (1)

  • Urine volume and osmolality and plasma PK assessments

    24 Hours

Study Arms (4)

Sugar pill

PLACEBO COMPARATOR
Drug: Placebo

VA106483 1 mg

EXPERIMENTAL
Drug: VA106483

VA106483 2 mg

EXPERIMENTAL
Drug: VA106483

VA106483 4 mg

EXPERIMENTAL
Drug: VA106483

Interventions

VA106483DRUG

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

VA106483 1 mgVA106483 2 mgVA106483 4 mg
PlaceboDRUG

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

Sugar pill

Eligibility Criteria

Age65 Years+
Sexmale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Male, Age: 65 years and above
  • Using adequate contraception
  • Medical history without clinically significant pathologies; no evidence of serious pathology or disease
  • Physical examination parameters without signs of serious disease
  • No clinically significant ECG and lab safety tests (sodium must be within normal range)
  • Willing and able to participate and provides written informed consent

You may not qualify if:

  • Cardiac insufficiency; signs or symptoms suggestive of heart failure or requiring treatment with diuretics
  • Supine arterial blood pressure higher than 170/100 mmHg or less than 105/60 mm Hg
  • Presence of poorly controlled endocrine disorders
  • Renal insufficiency, active hepatic and/or biliary disease
  • Hyponatraemia. Serum sodium level must be within normal limits
  • Syndrome of inappropriate antidiuretic hormone (ADH) secretion
  • Symptoms suggestive of psychogenic or habitual polydipsia or of diabetes insipidus
  • Known hypersensitivity to the IP or any constituent of the IP
  • Use of any non-prescription preparation within 72 hours prior to study entry, with the exception of defined pain killers
  • A history of alcohol abuse or drug addiction within the last 2 years
  • Positive screen for HIV, hepatitis B or C
  • Currently taking any diuretics or any concomitant medication known to be a cytochrome 3A4 inhibitor
  • 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, Overland Park, KS

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

June 10, 2009

First Posted

June 17, 2009

Study Start

June 1, 2009

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

May 23, 2018

Record last verified: 2018-05

Locations

US(1)