Blood and Urine Sample Collection From Healthy Volunteers

Completed

• Conditions: Healthy

• Registration Number: NCT05154409
• Lead Sponsor: Evotec International GmbH

Brief Summary

The aim of the study is to obtain blood and urine samples from healthy volunteers to serve as a healthy control group for cross-cohort comparisons.

Detailed Description

The aim of the study is to obtain peripheral venous blood samples and a urine sample from 100 healthy volunteers on one day at three different times of the day, to serve as a healthy control group for cross-cohort comparisons.

With the help of the urine and blood samples obtained in this context, a cohort of a healthy collective is to be established for further research purposes.

Study Timeline

• Study Start: 2021-02-22
• Primary Completion: 2021-05-27
• Study Completion: 2021-05-27
• Study First Submitted: 2021-07-13
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-29
• Last Update Submitted: 2021-11-29
• Study First Posted: 2021-12-13
• Last Update Posted: 2021-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Healthy male and female subjects aged 40-70 years.
• Caucasian
• Non-smokers or ex-smokers
• Body Mass Index (BMI): ≥18.5 and ≤32 kg/m2
• Presence of a negative SARS-CoV-2 PCR test.

Exclusion Criteria

• Complaints that may indicate the presence of an infection, including Covid-19.
• Pathological alcohol consumption.
• Positive alcohol breath test at the preliminary examination.
• Alcohol consumption within the last 24 hours before the start of sampling.
• History of drug dependence.
• Positive urine drug test during the preliminary examination.
• Clinically significant acute or chronic disease. In particular, chronic inflammation, rheumatological and other autoimmune diseases, diabetes and other metabolic diseases.
• Indications in the medical history or during the medical examination that may jeopardize the safety of the study participant by participating in the study.
• History of relevant clinically significant cardiovascular disorders or clinically relevant hyper- or hypotension or clinically relevant brady- or tachycardia at screening as assessed by an investigator.
• Heart rate <45/min after 5 minutes in a quiet sitting position.
• Heart rate >100/min after 5 minutes in a quiet sitting position.
• Systolic blood pressure of > 170 mmHg or < 90 mmHg.
• Diastolic blood pressure of > 95 mmHg and/or < 60 mmHg.
• Regular use of prescription medication within 3 months prior to inclusion in the research project.
• Use of non-prescription medications within 3 days prior to inclusion in the research project.
• Presence of clinically significant food intolerance and/or food allergy as assessed by the investigator.
• Medically relevant previous operations.
• Condition following radio- or chemotherapy.
• History of oncological diseases.
• Blood and/or plasma donation within the last 30 days prior to sample collection.
• Pregnant or nursing female.
• Employees of study site.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collection of blood samples from healthy volunteers to serve as a healthy control group.	1 day	There are no primary endpoints planned; endpoints will be specified in the individual research projects that will utilize the blood samples as a control group.
Collection of urine samples from healthy volunteers to serve as a healthy control group.	1 day	There are no primary endpoints planned; endpoints will be specified in the individual research projects that will utilize the urine samples as a control group.

Trial Locations

Locations (1)

CTC North; 🇩🇪 Hamburg, Germany