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

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.

Study Overview

• Status: Completed
• Conditions: Nocturia
• Intervention / Treatment: Drug: Sugar pill; Drug: VA106483

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.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Plymouth, United Kingdom
    • Veeda Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sugar pill	Drug: Sugar pill
Experimental: VA106483 2 mg	Drug: VA106483
Experimental: VA106483 4 mg	Drug: VA106483
Experimental: VA106483 8 mg	Drug: VA106483

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pharmacodynamic profile of VA106483

Secondary Outcome Measures

Outcome Measure
Pharmacokinetic profile of VA106483
Safety and tolerability of VA106483

Collaborators and Investigators

• Sponsor: Vantia Ltd
• Collaborators: Veeda Clinical Research

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2008
• Primary Completion (Actual): February 1, 2009
• Study Completion (Actual): March 1, 2009

Study Registration Dates

• First Submitted: February 18, 2009
• First Submitted That Met QC Criteria: April 8, 2009
• First Posted (Estimate): April 9, 2009

Study Record Updates

• Last Update Posted (Actual): October 31, 2018
• Last Update Submitted That Met QC Criteria: October 29, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lower Urinary Tract Symptoms; Urological Manifestations; Nocturia
• Other Study ID Numbers: 483-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No