Clinical trial · Interventional
Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered
Phase 1 Clinical Trial Study to Evaluate Pharmacokinetics and Safety Profile of BZ371A in a Gel Formulation, Applied on Healthy Men and Women Genitals
NCT05332340CI-TRIAL-00086919completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate pharmacokinetics, safety and tolerability profile of BZ371A topically administered in healthy patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction | — | UNRESOLVED | — |
| Erectile Dysfunction Following Radical Prostatectomy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Radical Prostatectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BZ371A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Healthy Patients
- description
- Healthy patients receiving topical application of BZ371A
- interventionNames
- Drug: BZ371A
Primary outcomes (15)
- measure
- Cmax
- timeFrame
- 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
- description
- Peak Plasma Concentration
- measure
- T1/2
- timeFrame
- 0 (Pre-dose), 15, 30, 60, 180 and 360 minutes post dose
- description
- Terminal half-life of BZ371A
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.