A Study of TAS-303 in Female Patients With Stress Urinary Incontinence

Study Overview
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Brief Summary
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The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic of TAS-303 in female patients with Stress Urinary Incontinence.

Detailed Description
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This study is double-blind, placebo-controlled crossover study. The main purpose of this study is to evaluate Urethral Pressure Profile Parameters in Stress Urinary Incontinence patients who will receive single dose of TAS-303 or Placebo.

Official Title
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A Phase I Study of TAS-303 in Female Patients With Stress Urinary Incontinence

Conditions
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Stress Urinary Incontinence

Intervention / Treatment
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* Drug: TAS-303 18mg single-dose
* Drug: Placebo 18mg single-dose
* Drug: TAS-303 9mg single-dose
* Drug: Placebo 9mg single-dose


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Patient has symptoms of Stress Urinary Incontinence (SUI) for at least 12 weeks prior to study entry Patient weights at least 45 kg and has body mass index (BMI) range of 18.0-30.0 kg/m2, inclusive, at screening Patient is positive in 1-hour pad weight test at screening Patient has at least 2 incontinence episodes per week. Key Exclusion Criteria: Patient has predominant or primary urge incontinence according to investigator judgment Patient had a prior surgical SUI treatment Patient is diagnosed Pelvic Organ Prolapse Patient is currently taking medication, or has taken medication in the last 4 weeks, for urinary incontinence or that effect urinary output function including anti-cholinergic or anti-histamines or any anti-anxiety medications. Patient is positive pregnancy test

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A<br>TAS-303 18mg single-dose and then Placebo single-dose. | Drug: TAS-303 18mg single-dose<br> <br> Drug: Placebo 18mg single-dose<br> <br> |
| Placebo Comparator: Treatment B<br>Placebo single-dose and then TAS-303 18mg single-dose. | Drug: TAS-303 18mg single-dose<br> <br> Drug: Placebo 18mg single-dose<br> <br> |
| Active Comparator: Treatment C<br>TAS-303 9mg single-dose and then Placebo single-dose. | Drug: TAS-303 9mg single-dose<br> <br> Drug: Placebo 9mg single-dose<br> <br> |
| Placebo Comparator: Treatment D<br>TAS-303 Placebo single-dose and then TAS-303 9mg single-dose. | Drug: TAS-303 9mg single-dose<br> <br> Drug: Placebo 9mg single-dose<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Maximum Urethral Closure Pressure (MUCP) |  | Baseline, 6 hours after the administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urethral pressure profile parameters: mean urethral closure pressure, functional profile length |  | Baseline, 6 hours after the administration | 
| Safety assessed by incidence and severity of adverse events |  | Up to 36 days after the administration | 
| Maximum plasma concentration (Cmax) of TAS-303 |  | 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration | 
| Time to maximum plasma concentration (tmax) of TAS-303 |  | 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration | 
| Area under the plasma concentration versus time curve (AUC) of TAS-303 |  | Immediately prior to dosing, and 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration | 
| Elimination half-time (t1/2) of TAS-303 |  | 1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Urinary Incontinence, Urinary Incontinence, Stress, Lower Urinary Tract Symptoms