NL-OMON43110
Completed
Not Applicable
Studying the variation of biological age in a healthy population - Biological age in healthy individuals
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Explorative research on age related disease specific biomarkers as endpoints in (pharmacological) intervention studies.
- Sponsor
- Janssen Prevention Center
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •1\. Healthy male and female volunteers aged 20 \* 30 years (including 30\), or 40 \* 50 (including 50\), or 60 \* 70 (including 70\). Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical history and a complete physical examination including urinalysis.
- •2\. Body Mass Index (BMI) below 30 kg/m².
- •3\. Ability to communicate well with the investigator in the Dutch language.
- •4\. Able to give written informed consent and willing to comply with all study\-related procedures, and have signed an informed consent prior to any study\-mandated procedure.
Exclusion Criteria
- •Eligible subjects must meet none of the following exclusion criteria on the study day:;1\. Are pregnant (positive pregnancy test) or lactating.
- •2\. Taking any prescription drugs within 14 days of the study day or within 5 times the elimination half\-life of the medication (whichever is longer), except female subjects who use contraceptives. Occasional acetaminophen/paracetamol is allowed. Exceptions may apply when, judged by the investigator, use of concomitant medication does not interfere with the study objectives.
- •3\. Currently have, or have history of, clinically significant pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal or genitourinary disease or cancer.
- •4\. Have had significant acute infection within two weeks of the study day.
- •5\. Positive test for drugs of abuse and/or positive alcohol test on the study day .
- •6\. Have a history of alcohol and/or drug abuse.
- •7\. Smoking more than 5 cigarettes or equivalent per day in the past 6 months prior to the study day and unable to abstain from smoking whilst in the unit.
- •8\. Donation or loss of blood over 500 mL within three months (males) or four months (females) days prior to the study day.
- •9\. Have any dermatological condition (including eczema, skin disease at vein puncture site, keloids or scarring) that, in the opinion of the investigator, could increase the risk of adverse events to the volunteer from the sampling procedure.
- •10\. Participation in a clinical trial within 90 days of the study day or more than 4 times in the previous year.
Outcomes
Primary Outcomes
Not specified
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