NCT02113020已完成1 期
A Randomized, Double-blind, Single-dose, 4 × 4 Crossover Phase I Study to Examine the Effects of TAK-233 on the Urethral Function in Healthy Female Subjects
Takeda0 个研究点目标入组 24 人开始时间: 2014年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 主要终点
- Change from baseline in motor threshold for urethral sphincter contraction.
研究概览
简要总结
The objective of this clinical trial is to examine the clinical pharmacology properties of TAK-233 in healthy female subjects
详细描述
The primary objective of this study is to examine the pharmacodynamics and the safety of TAK-233 administered as a single dose in healthy women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects who understand the contents of this clinical trial and who the investigator or sub-investigator consider able to comply with the procedures of the clinical trial
- •Subjects who can sign the informed consent form and can date the form without assistance before starting the procedures of the clinical trial
- •Healthy Japanese women
- •Subjects aged ≥ 20 and ≤ 40 years at the time of consent
- •Subjects with body weight ≥ 45 kg and BMI ≥18.5 and ≤ 25.0 kg/m2 at the time of screening
- •Women of child bearing potential who agree to take specified contraceptive measures regularly from the time of consent until 4 weeks after the end of the last assessment in the fourth treatment period
排除标准
- •Subjects who received TAK-233 within 16 weeks before the start of initial administration
- •Subjects who have previously received TAK-233 during treatment or during participation in another clinical trial
- •Employees of the medical institution conducting this clinical trial and their family/dependents (e.g., husband or wife, parents, children, and siblings), or subjects who may be coerced to agree to participate in the clinical trial
- •Subjects with poorly controlled and clinically significant neurological, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal (including chronic costiveness), urological (including dysuria), autoimmune, endocrine, or psychiatric diseases or other abnormalities which may affect the subject's participation in the clinical trial or results of the clinical trial
- •Subjects with hypersensitivity to TAK-233 related substances, or excipients of these products
- •Subjects whose urine tested positive for drug abuse at screening
- •Subjects with a history of drug abuse (defined as the use of illegal drugs) or alcohol dependence within 52 weeks before the screening assessments, or subjects who are not willing to stop alcohol intake or drug use during their participation in the clinical trial
- •Subjects who need to take prohibited concomitant medications, vitamins, or foods listed in listed in what?
- •Pregnant or lactating women, women expecting to be pregnant before giving consent, during this clinical trial, or within 4 weeks after the completion of this clinical trial, or women who are planning to donate their ova during this period
- •Subjects with currently active cardiovascular diseases, central nervous system diseases, hepatic diseases, hematopoietic diseases, renal failure, metabolic disorders, endocrine disorders, serious allergies, asthma, hypoxemia, hypertension, convulsion, allergic exanthema, or urological disorders (subjects with peptic ulcer, convulsive disorders, or arrhythmia also fall this category)
- •Subjects that have any of the following diseases/surgical interventions that may affect drug absorption: digestive system disorders (malabsorption, esophageal reflux, peptic ulcer, erosive oesophagitis, frequent heartburn (at least once a week), or surgical interventions (e.g., cholecystectomy), or subjects who have had prior history of any of these diseases/surgical interventions within the last 24 weeks
- •Subjects with a history of cancer (excluding subjects whose basal cell carcinoma has been in remission for at least 5 years
- •Subjects that have tested positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antigen/antibody, or syphilis serological reaction at screening
- •Subjects who took nicotine-containing products (e.g., cigarette, pipe tobacco, cigar, chewing tobacco, nicotine patch, and nicotine gum) within 28 days before hospitalization
- •Subjects for whom blood collection from peripheral veins is difficult
- •Subjects who donated at least 200 mL of whole blood within 4 weeks before the start of the initial administration, or subjects who donated at least 400 mL of whole blood within 16 weeks before the start of the initial administration
- •Subjects who donated at least 400 mL (in total) of whole blood within 52 weeks before the start of the initial administration
- •Subjects who donated blood components within 2 weeks before the start of the initial administration
- •Subjects with clinically significant abnormalities on the electrocardiogram recorded at screening or hospitalization (Day -1 of the first treatment period)
- •Subjects who had a QTcF interval of > 470 msec or a PR interval of < 120 msec or > 220 msec on the electrocardiogram recorded at screening or hospitalization
- •Subjects with a systolic blood pressure of < 100 mmHg or > 140 mmHg and a diastolic blood pressure of < 60 mmHg or > 90 mmHg at screening or hospitalization
- •Subjects with a heart rate of < 50 bpm or > 90 bpm at screening or hospitalization
- •Subjects unlikely to comply with the protocol, or subjects the investigator or sub-investigator considers ineligible for participation in the clinical trial due to other reasons
研究组 & 干预措施
TAK-233
Experimental
Oral administration
干预措施: TAK-233 (Drug)
Placebo
Placebo Comparator
Oral administration
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in motor threshold for urethral sphincter contraction.
时间窗: 6 hours post-dose
次要结局
- Number of participants with adverse events(Up to 28 days)
研究者
相似试验
未知
1 期
A phase I clinical pharmacology study of TAK-233 in healthy subjectsHealthy adult female subjectsJPRN-jRCT2080222396TAKEDA PHARMACEUTICAL COMPANY LTD.24
已完成
2 期
Efficacy and Safety of TAK-783 in Subjects With Rheumatoid ArthritisArthritis, RheumatoidNCT00760968Takeda224
已完成
1 期
Phase 1 TAK-041 First-in-Human Safety, Tolerability, and Pharmacokinetics StudyHealthy VolunteersSchizophreniaNCT02748694Neurocrine Biosciences114
已完成
1 期
Safety, Tolerability and Pharmacokinetics of TAK-438 in Healthy Male ParticipantsAscending Single Dose StudyNCT02123927Takeda108
已完成
2 期
Efficacy and Safety of TAK-583 in Subjects With Diabetic Peripheral NeuropathyDiabetic NeuropathiesNCT00760955Takeda338