This study aims to assess the safety of PSD506 in men with benign prostatic enlargement (BPE) / benign prostatic obstruction (BPO) and lower urinary tract symptoms (LUTS) and an IPSS of 8-19, in line with Americian Association recommendations. MedDRA version: 8.1 Level: LLT Classification code 10055026 Term: Prostatic obstruction
Conditions
Interventions
Product Name: PSD506
Product Code: PSD506
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: NA
CAS Number: NA
Current Sponsor code: PSD506
Other descriptive name: R032-02904/000
Concentration un
Sponsors
Plethora Solutions Limited
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: The study population is men with LUTS and BPE/bladder outlet obstruction (BOO): 1. Males aged 18 years and above. 2. Symptoms of LUTS for =6 months prior to baseline. 3. IPSS score of 8 - 19 at baseline. 4. Maximum urine flow =5 mL/sec and =12 mL/sec on 125 mL voided volume. 5. Post-void residual volume =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Uncontrolled hypertension >160/95 mmHg (after sitting for 5 minutes). 2. Concomitant or recent medication for BPE: 5a-reductase inhibitors within 6 months prior to baseline or alpha-adrenergic receptor blockers within 3 months prior to baseline. 3. Use of anticholinergics in the two weeks prior to baseline (four weeks for solifenacen). 4. Previous surgery for BOO. 5. Acute urinary retention in the 12 months prior to baseline. 6. Urinary tract infection within 6 weeks prior to baseline. 7. History of significant hypotensive episodes or symptoms of fainting, dizziness, or lightheadedness. 8. Unstable cardiovascular disease, particularly coronary artery disease, arrhythmias, atrial tachycardia, or congestive heart failure. 9. Clinically significant central nervous system disease including: Parkinson’s disease, multiple sclerosis, transient ischemic attack, stroke, seizure disorder, depression, or behavioural disturbances. 10. History of peripheral vascular or cerebrovascular disease. 11. History of narrow angle glaucoma or increased ocular pressure. 12. Clinically significant gastrointestinal disorder (e.g., gastroparesis, constipation, diarrhoea, colitis, gastrointestinal tract obstruction, hiatal hernia with reflux oesophagitis, cholestasis). 13. History of clinically significant liver disease, e.g., hepatitis B 14. Prohibited medications taken within two weeks prior to baseline. 15. Concomitant use of any agent that has a significant interaction with CYP3A4 or P glycoprotein (Pgp). 16. Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count [CBC], chemistry panel). 17. Participation in an investigational drug or device study within 30 days prior to screening. 18. Concomitant urological disorders: bladder neck stenosis, urethral stricture, bladder stones, bladder diverticulum, recurrent urinary tract infections, neurogenic bladder. 19. Diagnosed or suspected prostate cancer. 20. Known hypersensitivity to anti-cholinergic agents. 21. Unwillingness or inability to comply with the study protocol for any other reason. 22. Concomitant disease or condition that could interfere with, or for which the treatment might interfere with, the conduct of the study; or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study. This would include, but is not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease. 23. Any clinically significant abnormality on 12-lead ECG.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate the similarity in safety profiles between PSD506 and placebo as assessed by a urodynamic measure of bladder outlet obstruction (BOO);Secondary Objective: • To measure the change in post void residual volumes (PVR) and other urodynamic parameters • To obtain a preliminary assessment of efficacy by measuring the change in International Prostatic Symptom Score (IPSS) from baseline • To demonstrate the overall safety of PSD506 in this subject population ;Primary end point(s): Criteria for evaluation: Safety: The primary safety endpoint is the change from screening or baseline to Week 4 in detrusor pressure at maximum flow rate (pdetQmax). The secondary safety endpoints are: • Overall rates of urinary retention. • Change from screening or baseline to Week 4 in PVR volume. • Change from screening or baseline to Week 4 in urinary flow rate (Qmax). • Change from screening or baseline to Week 4 in volume to first detrusor contraction. • Change from screening or baseline to Week 4 in Bladder Outlet Obstruction Index (BOOI). • Change from screening or baseline to Week 4 in Bladder Contractility Index (BCI). • Change from screening or baseline to Week 4 in voiding efficiency. • Change from screening or baseline to Week 4 in maximum cystometric capacity. • Adverse events. • ECG: Mean change from screening to Week 4 in heart rate. Mean change from screening to Week 4 in QTc interval. • Antimuscarinic adverse events. • Vital signs. Efficacy: The measure of efficacy is the change from screening or baseline to Week 4 in IPSS. The secondary urodynamic endpoints will be considered indicative of efficacy, but in this study they are designated as safety assessments. | — |
Countries
Germany, Ireland, United Kingdom
Outcome results
None listed