The purpose of this study is to evaluate pharmacokinetics, safety and tolerability profile of BZ371A topically administered in healthy patients.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
12
Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Azidus Brasil Pesquisa Científica e Desenvolvimento
Valinhos, São Paulo, Brazil
Cmax
Peak Plasma Concentration
Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
T1/2
Terminal half-life of BZ371A
Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
AUC
Area under the curve (AUC) of plasma/serum/blood drug concentration-time curve
Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Clearance (CL)
Clearance of BZ371A
Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Vd
Distribution Volume of BZ371A
Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
Adverse Effects Evaluation
Number of Adverse Effects after compound application
Time frame: All adverse effect will be collected from the beginning of the study up to one week after drug administration
Physical Exam
Number of participants with abnormal physical exam findings
Time frame: Baseline and 1 week
Change in SBP
Number of participants with a significant change in Systolic Blood Pressure
Time frame: Baseline and 1 week
Change in DBP
Number of participants with a significant change in Diastolic Blood Pressure
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Time frame: Baseline and 1 week
Change in Heart Rate
Change in Heart Rate (HR). The data from this measure reflect changes calculated from the baseline.
Time frame: Baseline and 1 week
Change in Respiratory Rate
Change in Respiratory Rate (RR). The data from this measure reflect changes calculated from the baseline.
Time frame: Baseline and 1 week
Change in Temperature
Temperature measurements. The data from this measure reflect changes calculated from the baseline.
Time frame: Baseline and 1 week
Basal Chest Electrocardiogram (ECG)
Number of participants with abnormal ECG readings
Time frame: Baseline and 1 week
Blood Evaluation
Number of participants with abnormal laboratory test results
Time frame: Baseline and 1 day
Urine Evaluation
Number of participants with abnormal urinalysis
Time frame: Baseline and 1 week