Efficacy and Safety of VA106483 in Elderly Males

Nocturia Clinical Trial

Official title:

A Double-blind, Placebo-controlled Dose Response Study to Investigate Pharmacodynamics and Pharmacokinetics of Single and Repeated Oral Doses of VA106483 in Elderly Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00879138
• Other study ID #: 483-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: August 2008
• Est. completion date: March 2009

Study information

• Verified date: October 2018
• Source: Vantia Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A double blind, placebo-controlled, dose ranging study in males over the age of 65, who have a history of nocturia. The study will investigate pharmacodynamic outcomes (urine volumes and osmolality, circulating coagulation factors and haemodynamics) and pharmacokinetics, of both single and multiple oral doses of VA106483 at three dose levels, under conditions of controlled hydration.

Description:

VA106483 is a selective vasopressin V2 receptor agonist which is currently under development for the treatment of nocturia in males. This study examines the pharmacological action of VA106483 on markers of clinical efficacy (urine volumes and osmolality) and safety markers (coagulation factors and haemodynamics). The study will also assess the pharmacokinetics in the study population. The study design includes both cross-over and parallel phases so that pharmacodynamic and pharmacokinetic parameters can be assessed following both single and repeat dosing. Three dose levels will be given.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Males 65 years and above with history of nocturia

Exclusion Criteria:

• Any clinically significant concomitant medical disease, condition or abnormal laboratory test result

• Participation in any other clinical study within 30 days

• Intake of non-prescription medication within 14 days

Related Conditions & MeSH terms

• Nocturia

Intervention

Drug:
• VA106483

• Sugar pill

Locations

Country	Name	City	State
United Kingdom	Veeda Clinical Research	Plymouth

Sponsors (2)

Lead Sponsor	Collaborator
Vantia Ltd	Veeda Clinical Research

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacodynamic profile of VA106483
Secondary	Pharmacokinetic profile of VA106483
Secondary	Safety and tolerability of VA106483