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

Sponsor

Johanna Kujala (Other)

Overall Status

Completed

CT.gov ID

NCT04690673

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Healthy volunteersHealthy 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 :

Jan 15, 2021

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Apr 15, 2021

Arms and Interventions

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.

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

Primary Outcome Measures

Paracetamol concentration will be measured with the novel electrochemical method and mass-spectrometry. [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

Changes in serum lipidomics after administration of paracetamol [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

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Helsinki university hospital	Helsinki		Finland

Sponsors and Collaborators

Johanna Kujala

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Johanna Kujala, Sponsor-Investigator, Helsinki University Central Hospital

ClinicalTrials.gov Identifier:

NCT04690673

Other Study ID Numbers:

FEPODPara2020-1

First Posted:

Dec 31, 2020

Last Update Posted:

Dec 8, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Johanna Kujala, Sponsor-Investigator, Helsinki University Central Hospital

electrochemical

Paracetamol

Lipidomics

Endocannabinoid system

Additional relevant MeSH terms:

Acetaminophen

Study Results

No Results Posted as of Dec 8, 2021