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VA106483 Dose Response Study in Elderly Males

Primary Purpose

Nocturia

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

VA106483

Placebo

About this trial

This is an interventional treatment trial for Nocturia focused on measuring Nocturia, Pharmacokinetics, Pharmacodynamics, Water-loading, Elderly, Males

Eligibility Criteria

65 Years - undefined (Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Quintiles Phase I Services

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Sugar pill

VA106483 1 mg

VA106483 2 mg

VA106483 4 mg

Arm Description

Outcomes

Primary Outcome Measures

Urine volume and osmolality and plasma PK assessments

Secondary Outcome Measures

Full Information

NCT ID

NCT00922740

First Posted

June 10, 2009

Last Updated

May 21, 2018

Sponsor

Vantia Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00922740

Brief Title

VA106483 Dose Response Study in Elderly Males

Official Title

An Open Label, Escalation Study to Assess Intra-Subject Dose Response to VA106483 in Elderly Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vantia Ltd

4. Oversight

5. Study Description

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.

Detailed Description

VA106483 is intended to be used as a treatment for patients suffering from nocturia (defined as waking to urinate at least once per night between periods of sleep). Nocturia is a condition that often worsens as sufferers get older. This may be due to an over-active bladder muscle, the bladder being able to hold less urine at night-time or over production of urine in the bladder at night. The only antidiuretic approved for the treatment (in some countries) of nocturia is the peptide drug, desmopressin. However, as it can cause hyponatraemia in a proportion of patients above the age of 65 years it is contra-indicated in the elderly. This side-effect has not been observed with VA106483, making it potentially suitable for treating the elderly. The purpose of this study is to confirm that duration of action of VA106483 can be effectively controlled by dose and therefore that satisfactory clinical outcome in the treatment of nocturia can be achieved by individual dose titration. Subjects will be water-loaded, dosed with either VA106483 or placebo and then urine production will be monitored to assess any anti-diuretic effect.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nocturia

Keywords

Nocturia, Pharmacokinetics, Pharmacodynamics, Water-loading, Elderly, Males

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sugar pill

Arm Type

Placebo Comparator

Arm Title

VA106483 1 mg

Arm Type

Experimental

Arm Title

VA106483 2 mg

Arm Type

Experimental

Arm Title

VA106483 4 mg

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

VA106483

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Urine volume and osmolality and plasma PK assessments

Time Frame

24 Hours

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ralph Schutz

Organizational Affiliation

Quintiles Phase I Services, Overland Park, KS

Official's Role

Principal Investigator

Facility Information:

Facility Name

Quintiles Phase I Services

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66211

Country

United States

12. IPD Sharing Statement

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VA106483 Dose Response Study in Elderly Males

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