A Phase I Study of TAS-303 in Female Patients With Stress Urinary Incontinence
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change from baseline in Maximum Urethral Closure Pressure (MUCP)
研究概览
简要总结
The purpose of this study is to evaluate pharmacological effect, safety and pharmacokinetic of TAS-303 in female patients with Stress Urinary Incontinence.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Treatment C
TAS-303 9mg single-dose and then Placebo single-dose.
干预措施: TAS-303 9mg single-dose (Drug)
Treatment C
TAS-303 9mg single-dose and then Placebo single-dose.
干预措施: Placebo 9mg single-dose (Drug)
Treatment A
TAS-303 18mg single-dose and then Placebo single-dose.
干预措施: TAS-303 18mg single-dose (Drug)
Treatment A
TAS-303 18mg single-dose and then Placebo single-dose.
干预措施: Placebo 18mg single-dose (Drug)
Treatment B
Placebo single-dose and then TAS-303 18mg single-dose.
干预措施: TAS-303 18mg single-dose (Drug)
Treatment B
Placebo single-dose and then TAS-303 18mg single-dose.
干预措施: Placebo 18mg single-dose (Drug)
Treatment D
TAS-303 Placebo single-dose and then TAS-303 9mg single-dose.
干预措施: TAS-303 9mg single-dose (Drug)
Treatment D
TAS-303 Placebo single-dose and then TAS-303 9mg single-dose.
干预措施: Placebo 9mg single-dose (Drug)
结局指标
主要结局
Change from baseline in Maximum Urethral Closure Pressure (MUCP)
时间窗: Baseline, 6 hours after the administration
次要结局
- 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)
- 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)
- Elimination half-time (t1/2) of TAS-303(1, 2, 4, 6, 8, 12, 24, 48, 72 hours after the administration)