Blood and Urine Sample Collection From Healthy Volunteers

Healthy Clinical Trial

Official title:

Blood and Urine Sample Collection From Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05154409
• Other study ID #: EVT_CTC_01
• Status: Completed
• Start date: February 22, 2021
• Est. completion date: May 27, 2021

Study information

• Verified date: November 2021
• Source: Evotec International GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 27, 2021
• Est. primary completion date: May 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Locations

Country	Name	City	State
Germany	CTC North	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Evotec International GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of blood samples from healthy volunteers to serve as a healthy control group.	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.	1 day
Primary	Collection of urine samples from healthy volunteers to serve as a healthy control group.	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.	1 day