Study to look at the variability of tests of blood vessel function in several different groups of people

Not Applicable

Completed

• Conditions: Endothelial function and microcirculatory function; Circulatory System

• Registration Number: ISRCTN16578656
• Lead Sponsor: Centre for Human Drug Research

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/37177864/ (added 04/04/2024)

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-02-20
• Study Start: 2022-03-07
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Endothelial function and microcirculation measured with FMSF, LSCI, NIRS, SDFM and PLM on two study days

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures