Blood and Urine Sample Collection From Healthy Volunteers | NCT05154409

Studies
Blood and Urine Sample Collection From Healthy Volunteers

NCT05154409

Sponsor

Evotec International GmbH

Status

Completed

Last Update Posted

Dec 13, 2021Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 22, 2021Actual

Primary Completion Date

May 27, 2021Actual

Completion Date

May 27, 2021Actual

First Submitted Date

Jul 13, 2021

First Submission Date that Met QC Criteria

Nov 29, 2021

First Posted Date

Dec 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 29, 2021

Last Update Posted Date

Dec 13, 2021Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample