Phase 1 Clinical Trial Study to Evaluate Pharmacokinetics and Safety Profile of BZ371A in a Gel Formulation, Applied on Healthy Men and Women Genitals
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Cmax
研究概览
简要总结
The purpose of this study is to evaluate pharmacokinetics, safety and tolerability profile of BZ371A topically administered in healthy patients.
详细描述
Prostate cancer remains one of the most prevalent cancer in men. For its treatment, recent technological advances demonstrate that the most effective treatment is the Radical Prostatectomy (RP) procedure. However, although curative for Prostate Cancer, can result in damage to the cavernosal nerves.
The cavernosal autonomic nerves travel posterolaterally to the prostate to enter the penis and regulate blood flow and hence erection. Thus, damage caused by RP will affect NO tissue release and blood flow regulation, causing erectile dysfunction.
BZ371A has the ability to restore local blood flow regulation by a new and innovative mechanism of action and, therefore, has potential to be a supportive therapy for RP patients (restoring the erectile function).
Thus, this study has the purpose to evaluate safety, tolerability and pharmacokinetics of a BZ371A single dose, topically administrated at the genital area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men or women
- •Body mass index > 19 and < 28.5 Kg/m2
- •Is able to understand the Informed Consent Form (ICF)
排除标准
- •Women in their menstrual period;
- •Diseases that interfere with the absorption, distribution and excretion of drugs, such as history or presence of hepatic or renal diseases;
- •Presence of active genital lesions or sexually transmitted disease (STD) (such as herpes, gonorrhea, candidiasis, Human Papillomavirus, and others) that impair analysis of local adverse effects on the genitalia;
- •History of symptomatic hypotension, or diseases that increase the risk of symptomatic hypotension, such as patients with heart disease (including a history of angina and/or heart failure) and nephropathies;
- •Findings on ECG and/or laboratory tests that, in the investigator's judgment, are considered the research volunteer's participation or may interfere with the analysis of the study of the study;
- •Blood pressure (BP) outside the limits considered safe: systolic BP (SBP) 90 - 140 mmHg and diastolic BP diastolic BP (DBP) 60 - 90 mmHg, except for situations such as "white coat syndrome";
- •Any disease or condition or physical finding that the investigator considers significant and that increases the risk
- •Any disease or condition or physical finding that the investigator considers significant and that increases the risk of participation of the research volunteer or may interfere with the results.
研究组 & 干预措施
Healthy Patients
Healthy patients receiving topical application of BZ371A
干预措施: BZ371A (Drug)
结局指标
主要结局
Cmax
时间窗: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Peak Plasma Concentration
Change in DBP
时间窗: Baseline and 1 week
Number of participants with a significant change in Diastolic Blood Pressure
Change in Heart Rate
时间窗: Baseline and 1 week
Change in Heart Rate (HR). The data from this measure reflect changes calculated from the baseline.
T1/2
时间窗: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Terminal half-life of BZ371A
Clearance (CL)
时间窗: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Clearance of BZ371A
Vd
时间窗: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Distribution Volume of BZ371A
Adverse Effects Evaluation
时间窗: All adverse effect will be collected from the beginning of the study up to one week after drug administration
Number of Adverse Effects after compound application
Change in Temperature
时间窗: Baseline and 1 week
Temperature measurements. The data from this measure reflect changes calculated from the baseline.
AUC
时间窗: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Area under the curve (AUC) of plasma/serum/blood drug concentration-time curve
Physical Exam
时间窗: Baseline and 1 week
Number of participants with abnormal physical exam findings
Change in SBP
时间窗: Baseline and 1 week
Number of participants with a significant change in Systolic Blood Pressure
Change in Respiratory Rate
时间窗: Baseline and 1 week
Change in Respiratory Rate (RR). The data from this measure reflect changes calculated from the baseline.
Basal Chest Electrocardiogram (ECG)
时间窗: Baseline and 1 week
Number of participants with abnormal ECG readings
Blood Evaluation
时间窗: Baseline and 1 day
Number of participants with abnormal laboratory test results
Urine Evaluation
时间窗: Baseline and 1 week
Number of participants with abnormal urinalysis
次要结局
未报告次要终点