HealthyNCT05154409
Blood and Urine Sample Collection From Healthy Volunteers
An observational study of Healthy, run by Evotec International GmbH at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 22 Feb 2021to 27 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers who met all inclusion and none of the exlusion criteria
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start22 Feb 2021
- Primary completion27 May 2021
- Study completion27 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Evotec International GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hanna Peradziryi, Study chair, Hanna.Peradziryi@evotec.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05154409
- Sponsor's protocol ID
- EVT_CTC_01
- Status last verified
- Nov 2021
- First submitted
- 13 Jul 2021
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood and Urine Sample Collection From Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05154409
- Acronym / sponsor ID
- EVT_CTC_01
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Evotec International GmbHIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 27 May 2021 (actual)
- First posted
- 13 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers who met all inclusion and none of the exlusion criteria
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanna Peradziryi study chair
Hanna.Peradziryi@evotec.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Evotec International GmbH at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of blood samples from healthy volunteers to serve as a healthy control group. (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.