Clinical trial NCT05154409: Blood and Urine Sample Collection From Healthy Volunteers
Official title: Blood and Urine Sample Collection From Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Evotec International GmbH
Sponsor class: INDUSTRY
First posted: 2021-12-13
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Volunteers who met all inclusion and none of the exlusion criteria

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.

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-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.

Primary outcomes:
measure: Collection of blood samples from healthy volunteers to serve as a healthy control group.
timeFrame: 1 day
measure: Collection of urine samples from healthy volunteers to serve as a healthy control group.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: CTC North
Study officials:
affiliation: Hanna.Peradziryi@evotec.com
name: Hanna Peradziryi
role: STUDY_CHAIR
References: