NCT00879138

Efficacy and Safety of VA106483 in Elderly Males

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Vantia Ltd · Industry
• Sex: Male
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Nocturia

Interventions

Type	Name	Description
DRUG	VA106483
DRUG	Sugar pill

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-02-01
• Completion: 2009-03-01
• First posted: 2009-04-09
• Last updated: 2018-10-31

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study