Erectile Dysfunction Following Radical Prostatectomy, Erectile Dysfunction, Prostate Cancer, Radical Prostatectomy
Conditions
Keywords
Erectile Dysfunction, Radical Prostatectomy, Prostate Cancer
Brief summary
The purpose of this study is to evaluate pharmacokinetics, safety and tolerability profile of BZ371A topically administered in healthy patients.
Detailed description
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.
Interventions
DRUGBZ371A
Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
Sponsors
Azidus Brasil Scientific Research and Development Ltda
Biozeus Biopharmaceutical S.A.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Men or women * Body mass index \> 19 and \< 28.5 Kg/m2 * Is able to understand the Informed Consent Form (ICF)
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose | Peak Plasma Concentration |
| T1/2 | 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose | Terminal half-life of BZ371A |
| AUC | 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 |
| Clearance (CL) | 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose | Clearance of BZ371A |
| Vd | 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose | Distribution Volume of BZ371A |
| Adverse Effects Evaluation | 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 |
| Physical Exam | Baseline and 1 week | Number of participants with abnormal physical exam findings |
| Change in SBP | Baseline and 1 week | Number of participants with a significant change in Systolic Blood Pressure |
| Change in DBP | Baseline and 1 week | Number of participants with a significant change in Diastolic Blood Pressure |
| Change in Heart Rate | Baseline and 1 week | Change in Heart Rate (HR). The data from this measure reflect changes calculated from the baseline. |
| Change in Respiratory Rate | Baseline and 1 week | Change in Respiratory Rate (RR). The data from this measure reflect changes calculated from the baseline. |
| Change in Temperature | Baseline and 1 week | Temperature measurements. The data from this measure reflect changes calculated from the baseline. |
| Basal Chest Electrocardiogram (ECG) | Baseline and 1 week | Number of participants with abnormal ECG readings |
| Blood Evaluation | Baseline and 1 day | Number of participants with abnormal laboratory test results |
| Urine Evaluation | Baseline and 1 week | Number of participants with abnormal urinalysis |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Patients Healthy patients receiving topical application of BZ371A
BZ371A: Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A. | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Healthy Patients |
|---|---|
| Age, Continuous Healhty Participants | 39.30 years STANDARD_DEVIATION 9.18 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 2 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Patients | Adverse Effects Evaluation | 2 adverse events |
Primary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthy Patients | AUC | NA ng*min |
Primary
Basal Chest Electrocardiogram (ECG)
Number of participants with abnormal ECG readings
Time frame: Baseline and 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Patients | Basal Chest Electrocardiogram (ECG) | 0 participants |
Primary
Blood Evaluation
Number of participants with abnormal laboratory test results
Time frame: Baseline and 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Patients | Blood Evaluation | 0 participants |
Primary
Change in DBP
Number of participants with a significant change in Diastolic Blood Pressure
Time frame: Baseline and 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Patients | Change in DBP | 2 participants |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Patients | Change in Heart Rate | 69.42 bpm | Standard Deviation 12 |
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Patients | Change in Respiratory Rate | 19 breaths per minute | Standard Deviation 1 |
Primary
Change in SBP
Number of participants with a significant change in Systolic Blood Pressure
Time frame: Baseline and 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Patients | Change in SBP | 1 participants |
Primary
Change in Temperature
Temperature measurements. The data from this measure reflect changes calculated from the baseline.
Time frame: Baseline and 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Healthy Patients | Change in Temperature | 0.1 degrees Celsius | Standard Deviation 0.36 |
p-value: 0.683Kruskal-Wallis
Primary
Clearance (CL)
Clearance of BZ371A
Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthy Patients | Clearance (CL) | NA mL/min |
Primary
Cmax
Peak Plasma Concentration
Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthy Patients | Cmax | NA ng/mL |
Primary
Physical Exam
Number of participants with abnormal physical exam findings
Time frame: Baseline and 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Patients | Physical Exam | 0 participants |
Primary
T1/2
Terminal half-life of BZ371A
Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthy Patients | T1/2 | NA minutes |
Primary
Urine Evaluation
Number of participants with abnormal urinalysis
Time frame: Baseline and 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Healthy Patients | Urine Evaluation | 0 participants |
Primary
Vd
Distribution Volume of BZ371A
Time frame: 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Healthy Patients | Vd | NA mL |