None listed
Conditions
Brief summary
This study is testing a nasal spray called SDS089 in adults who have been newly diagnosed with pulmonary arterial hypertension (PAH), a condition that affects blood flow in the lungs. Participants will receive a single dose of the nasal spray during a routine heart catheterisation procedure, allowing researchers to measure how it affects blood pressure and circulation in the lungs before and after treatment. The study also aims to assess the safety and tolerability of the treatment. The study hypothesises that a single dose of SDS089 will reduce resistance in the lung blood vessels, improving blood flow shortly after administration.
Interventions
Intervention: SDS089 Nasal Spray (vardenafil hydrochloride trihydrate nasal spray)
Administration: Intranasal, one spray in each nostril, equating to 2.5 mg Vardenafil, self-administered by participant after training on the use of spray device
Duration: Once during right heart catheterisation
Sponsors
LTR Pharma Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All subjects must meet all the following inclusion criteria: 1. Able to read, understand, and voluntarily provide written informed consent using an informed consent form (ICF); 2. Hemodynamic Confirmation of PAH: a. Mean pulmonary artery pressure (mPAP) greater than or equal to 25 mmHg b. Pulmonary vascular resistance (PVR) greater than or equal to 3 Wood units c. Pulmonary capillary wedge pressure (PCWP) less than or equal to 15 mmHg 3. No prior therapy for PAH or no current treatment for previously diagnosed PAH. 4. Adult aged greater than or equal to 18 years at the time of informed consent; 5. Body mass index (BMI) between 18 and 32 kg/m2 inclusive; 6. Able to communicate adequately with the Investigator and study team and agrees to and is able to comply with the requirements of the study, including the use of the nasal spray.
Exclusion criteria
Any of the following criteria will exclude subjects from study participation: 1. Subject has a history or presence of significant cardiovascular condition that would be contraindicated for Cath Lab inhibition, or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the Investigator; 2. A predisposition to priapism, such as subjects with sickle cell disease, dyscrasias, multiple myeloma or blood dyscrasias; 3. Left ventricular outflow tract obstruction, such as idiopathic hypertrophic subaortic stenosis (IHSS) or aortic stenosis (AS), clinically significant cardiomyopathy, moderate or severe cardiac ischemic or valvular disease; 4. Systolic BP <90; diastolic BP NYHA Class II; 12. Use of vardenafil or related medicines in this class (i.e., sildenafil, avanafil, or tadalafil) within 4 weeks prior to screening; 13. Any hepatic analyte (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP], gamma-glutamyl transferase [GGT], or total bilirubin) value above 2-fold the upper limit of reference at Screening. The hepatic analyte test(s) may be repeated once at the discretion of the Investigator; 14. History or risk of seizures; 15. Any nasal abnormality, including but not limited to: chronic sinusitis, nasal surgery, abnormality of the IN cavity, deviated septum, nasal/sinus polyps; 16. Are an employee, family member, or student of the Investigator or clinical site(s), or Sponsor. 17. Previous participation in any other investigational study of SDS089 Nasal Spray.
Outcome results
None listed