Blood and Urine Sample Collection From Healthy Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Healthy

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 20251
    • CTC North

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers who met all inclusion and none of the exlusion criteria

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Evotec International GmbH
• Investigators: Study Chair: Hanna Peradziryi, Hanna.Peradziryi@evotec.com

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2021
• Primary Completion (Actual): May 27, 2021
• Study Completion (Actual): May 27, 2021

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 13, 2021

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: November 29, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: EVT_CTC_01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No