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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00879138

Enrollment

Registered

2009-04-09

Start date

2008-08-31

Completion date

2009-03-31

Last updated

2018-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nocturia

Brief 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.

Interventions

DRUGVA106483

DRUGSugar pill

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Pharmacodynamic profile of VA106483	—

Secondary

Measure	Time frame
Pharmacokinetic profile of VA106483	—
Safety and tolerability of VA106483	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026