Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate pharmacokinetics, safety and tolerability profile of BZ371A topically administered in healthy patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Healthy Patients Healthy patients receiving topical application of BZ371A |
Drug: BZ371A
Single dose topical administration of 1.5 mL with a concentration of 5 mg/mL of BZ371A.
|
Outcome Measures
Primary Outcome Measures
- 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]
Adverse effect evaluation of compound use and application
- Physical Exam [Baseline and 1 week]
Number of participants with abnormal physical exam findings
- Change in SBP [Baseline and 1 week]
Change in Systolic Blood Pressure
- Change in DBP [Baseline and 1 week]
Change in Diastolic Blood Pressure
- Change in Heart Rate (HR) [Baseline and 1 week]
Change in Heart Rate
- Change in Respiratory Rate (RR) [Baseline and 1 week]
Respiratory Rate
- Change in Temperature [Baseline and 1 week]
Temperature measurements
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men or women
-
Body mass index > 19 and < 28.5 Kg/m2
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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;
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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;
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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;
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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";
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Any disease or condition or physical finding that the investigator considers significant and that increases the risk
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Azidus Brasil Pesquisa Científica e Desenvolvimento | Valinhos | São Paulo | Brazil |
Sponsors and Collaborators
- Biozeus Biopharmaceutical S.A.
- Azidus Brasil Scientific Research and Development Ltda
Investigators
- Principal Investigator: Regina M Doi, Azidus Brasil Pesquisa Científica e LTDA
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BZ371ACLI003