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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04690673
Recruitment Status : Completed
First Posted : December 31, 2020
Last Update Posted : December 8, 2021
Sponsor:
Information provided by (Responsible Party):
Johanna Kujala, Helsinki University Central Hospital

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Drug Mechanism Healthy Drug: Paracetamol Diagnostic Test: Paracetamol concentration measurements and lipidomic assessment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Healthy volunteers
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Detection of Paracetamol Concentration in Blood-, Saline- and Urine Samples With an Electrochemical Indicator in Healthy Volunteers - a Validation Study for a Novel Technique
Actual Study Start Date : January 15, 2021
Actual Primary Completion Date : March 31, 2021
Actual Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Study group
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
1 g oral paractamol

Diagnostic Test: Paracetamol concentration measurements and lipidomic assessment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Paracetamol concentration will be measured with the novel electrochemical method and mass-spectrometry. [ Time Frame: 1 day ]
    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.


Secondary Outcome Measures :
  1. Changes in serum lipidomics after administration of paracetamol [ Time Frame: 1 day ]
    Mechanism of action of paracetamol is not exactly known. We will assess changes in serum lipidomic measurement after paracetamol administration in healthy individuals


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04690673


Locations
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Finland
Helsinki university hospital
Helsinki, Finland
Sponsors and Collaborators
Johanna Kujala
More Information
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Responsible Party: Johanna Kujala, Sponsor-Investigator, Helsinki University Central Hospital
ClinicalTrials.gov Identifier: NCT04690673    
Other Study ID Numbers: FEPODPara2020-1
First Posted: December 31, 2020    Key Record Dates
Last Update Posted: December 8, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Johanna Kujala, Helsinki University Central Hospital:
electrochemical
Paracetamol
Lipidomics
Endocannabinoid system
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics