- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00922740
VA106483 Dose Response Study in Elderly Males
An Open Label, Escalation Study to Assess Intra-Subject Dose Response to VA106483 in Elderly Male Subjects
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
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Kansas
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Overland Park, Kansas, United States, 66211
- Quintiles Phase I Services
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Sugar pill
|
Placebo on Day 1, 1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
|
Experimental: VA106483 1 mg
|
Placebo on Day 1, 1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
|
Experimental: VA106483 2 mg
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Placebo on Day 1, 1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
|
Experimental: VA106483 4 mg
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Placebo on Day 1, 1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Urine volume and osmolality and plasma PK assessments
Time Frame: 24 Hours
|
24 Hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ralph Schutz, Quintiles Phase I Services, Overland Park, KS
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 483-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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