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Clinical Trials/NCT05154409
NCT05154409
Completed
Not Applicable

Blood and Urine Sample Collection From Healthy Volunteers

Evotec International GmbH1 site in 1 country100 target enrollmentFebruary 22, 2021
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
Evotec International GmbH
Enrollment
100
Locations
1
Primary Endpoint
Collection of blood samples from healthy volunteers to serve as a healthy control group.
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 22, 2021
End Date
May 27, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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-
  • 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.

Outcomes

Primary Outcomes

Collection of blood samples from healthy volunteers to serve as a healthy control group.

Time Frame: 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.

Time Frame: 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.

Study Sites (1)

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