Endothelial function and microcirculatory function Circulatory System
Conditions
Interventions
Eight healthy volunteers will be assessed in this study on two separate study days. The Screening Visit will be conducted at day 1. Each study day subjects will undergo a battery of endothelial testin
Sponsors
Centre for Human Drug Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male and females, 18 to 30 years of age, inclusive. 2. Subject has voluntarily signed informed consent form. 3. Willingness and ability to comply with all study procedures 4. Body mass index (BMI) between 18 and 30 kg/m²
Exclusion criteria
Exclusion criteria: 1. Evidence of any active or chronic disease or condition that could interfere with the conduct of the study (following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature). 2. Receival of any study drug within 30 days or 5 times ½ half-life, whichever greater prior to day 1. 3. Participation in an investigational drug or device study (last dosing of previous study was within 90 days prior to first dosing of this study). 4. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agent. 5. Alcohol intake 24h prior to the study day. 6. Is demonstrating excess in caffeine consumption (more than eight cups of coffee or equivalent per day. 7. If a woman, pregnant, or breast-feeding, or planning to become pregnant during the study 8. Any daily nicotine use or regular use of nicotine products. 9. Positive nasopharyngeal rapid antigen test for SARS-CoV-2 at admission to the clinical research center 10. Subject has received any vaccination in the last 2 weeks prior to Visit 1
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Endothelial function and microcirculation measured with FMSF, LSCI, NIRS, SDFM and PLM on two study days | — |
Secondary
| Measure | Time frame |
|---|---|
| There are no secondary outcome measures | — |
Countries
Netherlands
Outcome results
None listed