NCT03102489已完成1 期
Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BP101 After Multiple Doses Administration in Healthy Volunteers
Ivix LLX1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2017年2月22日最近更新:
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
- 18
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent Adverse Events
研究概览
简要总结
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of BP101 in Healthy Volunteers.
详细描述
Double-blind, randomized, placebo-controlled study of the safety, tolerability, pharmacokinetics and pharmacodynamics of BP101 after multiple doses administration in healthy volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy women aged from 18 to 40, inclusive.
- •Verified diagnosis "healthy": absence gastrointestinal, hepatic, renal, cardiovascular, endocrine, central nervous system, ear, nose, throat (ENT) and gynecological disorders (performed standard clinical, laboratory and instrumental assessments did not reveal any disorders).
- •Body mass index (BMI) within range from 18.5 to 30 kg/m^
- •Subject consent not to intake alcohol during the entire study period; negative alcohol breath test at screening and before start of Investigational Product administration.
- •Negative pregnancy test result at screening and before start of Investigational Product administration.
- •Consent to use adequate methods of contraception throughout the study.
- •Normal regular menstrual cycle of 28 +/- 7 days duration for at least 6 months before study enrollment.
- •Women with stable sexual partner.
排除标准
- •Chronic cardiovascular, respiratory, neuroendocrine, genitourinary systems disorders, as well as gastrointestinal, hepatic, renal, blood, and ENT disorders (including acute and chronic rhinitis, sinusitis, and others).
- •Gynecological disorders (polycystic ovary syndrome, mommas, endometriosis, inflammatory diseases and others).
- •Positive cervical cytology Papanicolaou (PAP) test in medical anamnesis within 12 months before screening.
- •Lab abnormalities (blood hematology and biochemistry and urinalysis) at screening.
- •Electrocardiogram (ECG) abnormalities at screening, and before start of Investigational Product administration.
- •Systolic blood pressure in a sitting position below 100 mm Hg or above 140 mm Hg; and/or diastolic pressure below 60 mm Hg or above 90 mm Hg at screening and before start of Investigational Product administration.
- •Heart rate less than 60 beats/min or more than 90 beats/min at screening, and before start of Investigational Product administration.
- •Signs of malignant neoplasms in medical history, during the examination at any time prior to start of Investigational Product administration.
- •Psychiatric disorders (including any form of schizophrenia, epilepsy, bipolar affective disorder and others), intake of psychotropic agents.
- •Chronic pain syndromes (including chronic pelvic pain syndrome).
- •Acute infections within 4 weeks before screening.
- •Regular intake of medications (including nonprescription drugs, vitamins, and Supplements) within 2 weeks before screening.
- •Intake of more than 5 units of alcohol per week (1 unit of alcohol is equivalent to 0.5 liter of beer, 200 ml wine or 30 ml of spirit (pure alcohol)) or historical information about alcoholism, substance abuse, prescription drug abuse.
- •Smoking more than 10 cigarettes a day.
- •Pregnancy or breastfeeding, positive urine pregnancy at screening and before the start of Investigational Product administration.
研究组 & 干预措施
BP101
Experimental
Treatment with BP101
干预措施: BP101 (Drug)
Placebo
Placebo Comparator
Treatment with placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence of treatment-emergent Adverse Events
时间窗: 6 weeks
To evaluate frequency, seriousness, and severity of adverse events, including events of dose-limiting toxicity in healthy volunteers receiving different doses of BP101 compared to placebo after multiple administrations.
次要结局
- BP101 half-life time (T1/2)(Day 1)
- Change from Baseline in Female Sexual Function questionnaire score(6 weeks)
- BP101 maximum plasma concentration (Cmax)(Day 1)
- Change from Baseline in Female Sexual Distress Scale-Revised score(6 weeks)
- Change from Baseline in Female Sexual Function Index score(6 weeks)
- BP101 area under the concentration versus time curve (AUC)(Day 1)
- BP101 time to maximum plasma concentration (Tmax)(Day 1)
- Change from Baseline in Arizona Sexual Experience Scale score(6 weeks)
研究者
研究点 (1)
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