Pharmacodynamic study on blood pressure and pulse rate in healthy volunteers Not Applicable
Conditions
Interventions
The randomization list was computer-generated by the Biometry Unit of the Clinical Contract Research Organization (CRO), using the PLAN procedure of SAS® version 9.3 (TS1M1). The randomization list wa
Sponsors
IBSA Institut Biochimique (Switzerland)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Informed consent: signed written informed consent before inclusion in the study 2. Sex and Age: males, 18-45 inclusive (young) versus =65 (elderly) years old 3. Body Mass Index: 18.5-30 kg/m2 inclusive 4. Vital signs: systolic blood pressure 100-139 mmHg, diastolic blood pressure 50-89 mmHg, heart rate 50-90 bpm, measured after 5 min at rest in the sitting position 5. Full comprehension: the ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to cooperate with the Investigator and to comply with the requirements of the entire study
Exclusion criteria
Exclusion criteria: 1. Electrocardiogram (12-lead ECG in supine position): clinically significant abnormalities 2. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study; presence or history (within 28 days) of any tongue piercings 3. Laboratory analyses: clinically significant abnormal laboratory values indicative of physical illness 4. Allergy: ascertained or presumptive hypersensitivity to the active principle (PDE5 inhibitors) and/or formulations' ingredients; history of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may affect the outcome of the study 5. Diseases: significant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, skin, hematological, endocrine or neurological diseases that may interfere with the aim of the study; history of vision or hearing problems related to drugs of the PDE5 inhibitor pharmacological class; history of priapism; anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie’s disease); history of ophthalmologic diseases like non-arteritic anterior ischemic optic neuropathy or retinitis pigmentosa 6. Medications: medications, including over-the-counter medications and herbal remedies for 2 weeks before the screening visit 7. Nitrates: treatment with nitrates for 2 weeks before the screening visit 8. Investigative drug studies: participation in the evaluation of any investigational product for 3 months before this study. The 3-month interval is calculated as the time between the first calendar day of the month that follows the last visit of the previous study and the first day of the present study 9. Blood donation: blood donations for 3 months before this study 10. Drug, alcohol, caffeine, tobacco: history of drug, alcohol [>2 drinks/day, defined according to the USDA Dietary Guidelines 2015-2020], caffeine (>5 cups coffee/tea/day) or tobacco abuse (?10 cigarettes/day) 11. Drug test: positive result at the drug test at screening or day-1 12. Alcohol test: positive alcohol breath test at day -1 13. Diet: abnormal diets (3500 kcal/day) or substantial changes in eating habits in the 4 weeks before this study; vegetarians
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome was to evaluate the pharmacodynamic effects on blood pressure and pulse rate in healthy male subjects after a single dose of the 3 investigational medicinal products as compared to placebo in terms of: 1. Maximum change from pre-dose blood pressure and pulse rate expressed as a post-dose maximum decrease in blood pressure or maximum increase in pulse rate 2. Mean change from pre-dose in blood pressure and pulse rate across all post-dose time points 3. Proportion of subjects with a clinically significant decrease in blood pressure 4. Proportion of subjects with a clinically significant increase in heart rate 5. Proportion of subjects with symptomatic hypotension, defined as palpitations, tachycardia, visual disturbances, blurry vision, nausea, vomiting, dizziness, syncope, hypotension and pallor In addition, hemodynamic responses to sildenafil were evaluated in healthy young (=45yrs) and elderly (=65yrs) male volunteers. Measures of systolic and diastolic blood pressure and pulse rate and their changes from the pre-dose mean were done at rest in a supine position for the first 4 hours after administration with ambulatory blood pressure monitoring (ABPM) at the following times: -15, -10 and -5 min pre-dose and 15, 30, 45 min and 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 5, 7 and 10 h post-dose (i.e., every 15 min for 4 h post-dose and at 5, 7 and 10 h post-dose). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome was to collect safety and tolerability data after a single dose of T1, T2, T3 and T3 matching placebo and measured using the following assessments: treatment-emergent adverse events collection, manually measured vital signs (blood pressure and heart rate), body weight, physical examination, ECG, laboratory assays. Method of measurement: 1. Treatment-emergent adverse events recordings throughout the study duration 2. Vital signs: blood pressure (BP) and heart rate (HR) were measured by the Investigator or their deputy after 5 min at rest (in a sitting position) at screening and ETV, if applicable or final visits. 3. 12-Leads ECGs were performed in a supine position at screening and final visit/ETV 4. Body weight was recorded at screening and final visit/ETV. Subjects were weighed (kg) while lightly clothed without shoes. Height was measured at screening only and BMI was recorded. BMI was calculated as weight [kg]/(height [m] x height [m]). 5. Laboratory parameters: blood and urine samples were collected at screening and final visits. | — |
Countries
Italy, Switzerland
Contacts
Public ContactValeria Frangione
Outcome results
None listed