Vardenafil Nasal Spray in healthy volunteers including over 65's (15 days confinement in Sydney)
Phase 1, Randomised, Open-label, Single- and Multiple-dose Study to Evaluate and Compare the Pharmacokinetics and Safety of SDS089 Nasal Spray to Vardenafil Tablets in Healthy Male Subjects
LTR Pharma Ltd
27 participants
Jan 21, 2026
Interventional
Conditions
Summary
The study will compare blood levels of vardenafil between SDS089, a new nasal spray and tablets. In Part A each participant will receive a single dose of SDS089 2.5 mg, SDS089 5 mg and vardenafil tablet 20 mg with a 3-day washout period between dosing. In Part B each participant will receive a daily dose of SDS089 5 mg for five days. Participants will be confined in the clinical trial unit for the duration of the study (15 days).
Eligibility
Inclusion Criteria6
- Confirmed as healthy
- Adult male aged 18 years or over
- Approximately half of the patients will be 65 or over.
- Body mass index (BMI) >=18 and <=32 kg/m2
- Willing to abstain from smoking, alcohol, caffeine and/or illegal drugs during the study
- Not taking blood pressure medications
Exclusion Criteria11
- A predisposition to priapism e.g. sickle cell disease, multiple myeloma or blood dyscrasias
- Known history of cardiovascular or cerebrovascular events e.g. myocardial infarction, stroke, life-threatening arrhythmia or coronary revascularization within the past 6 months, unstable angina, angina with sexual intercourse, or congestive heart failure > New York Heart Assessment Class II
- Current hypertensive medication
- Systolic blood pressure 150 mmHg; diastolic BP 95 mmHg, orthostatic hypotension
- History of drug or alcohol abuse or dependence
- Prostate Specific Antigen >4 ng/mL, previous radical prostatectomy
- History of type 1 or type 2 diabetes
- Use of any of the following drugs: nitrates, nitric oxide donors, alpha-blockers, class IA or III antiarrhythmics, or antihypertensive medications, ritonavir, cobicistat, indinavir, saquinavir, atazanavir, ketoconazole, itraconazole, clarithromycin, and erythromycin, riociguat, poppers or vardenafil or related medicines in this class (i.e., sildenafil, avanafil, or tadalafil) within 30 days prior to study
- Any use of tobacco or nicotine products within 6 months prior to study
- Received treatment for any type of internal cancer within 5 years
- Nasal abnormality, e.g. chronic sinusitis, nasal surgery, abnormality of the intranasal cavity, deviated septum, nasal/sinus polyps
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Interventions
SDS089 is being developed to help men with erectile dysfunction. Part A: Each participant will be randomised to receive a single dose of each treatment with a 3-day washout period. Treatments: (a) SDS089 Nasal Spray, 2.5 mg, (b) SDS089 Nasal Spray, 5 mg, and (c) Vardenafil Tablet, 20 mg. Part B (will follow on after a 3-day washout period): Each participant will receive a daily dose of SDS089 Nasal Spray, 5 mg for five days. Participants will be confined in the clinical trial unit for the duration of the study (15 days). All doses will be self-administered under the supervision of the clinical staff at the site who will confirm administration.
Locations(1)
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ACTRN12626000048381