Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples - a Validation Study for a Novel Technique

Study Overview
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Brief Summary
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The main objective is to assess whether a novel electrochemical tool is reliable in detecting concentration of paracetamol in fingerprick- , saline-, urine-, and serum samples. We will recruit 12 healthy volunteers aged 18-45. They will get 1 g oral paracetamol. Paracetamol concentration will be detected from abovementioned samples at timely intervals for 24 hours, analyzed with the novel electrochemical method and compared to gold standard mass-spectrometry analysis. Despite of extensive use, the mechanism of action of parasetamol is not completely understood. The central serotonergic system may play a role. Endocannabinoid system is a group of lipid mediators, that possibly is involved in mediating paracetamol effect to the serotonergic system. Serum lipidomic assessment can be used to study endocannabinoid metabolics. In this study we will try to assess changes in endocannabinoid system by looking into serum lipidomics in order to understand the mechanism of action of paracetamol.

Official Title
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Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples With an Electrochemical Indicator in Healthy Volunteers - a Validation Study for a Novel Technique

Conditions
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Drug Mechanism, Healthy

Intervention / Treatment
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* Drug: Paracetamol
* Diagnostic Test: Paracetamol concentration measurements and lipidomic assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, no medication of any kind. Age 18-45 BMI 18.5 - 30 Informed consent Exclusion Criteria: Pregnancy, lactation. prisoner smoking less than 3 months from prior blood donation or clinical pharmacological study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Healthy volunteers
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>All healthy volunteers are in this group. They receive 1g paracetamol orally. Saline-, urine-, venous blood and fingerprick samples will be collected at timely intervals. | Drug: Paracetamol<br>* 1 g oral paractamol<br>Diagnostic Test: Paracetamol concentration measurements and lipidomic assessment<br>* Paracetamol concentration is measured from saline-, urine-, venous blood- and fingerprick- samples at timely intervals. Also serum lipidomic assessment is performed from venous blood samples.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Paracetamol concentration will be measured with the novel electrochemical method and mass-spectrometry. | Paracetamol concentration will be measured with the novel electrochemical method and gold standard mass-spectrometry. Measurements are made from fingerprick-, venous blood-, saliva-, and urine samples. Measured concentrations are compared between matrixes and between laboratory analysis techniques. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in serum lipidomics after administration of paracetamol | Mechanism of action of paracetamol is not exactly known. We will assess changes in serum lipidomic measurement after paracetamol administration in healthy individuals | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electrochemical, Paracetamol, Lipidomics, Endocannabinoid system