Pharmacokinetics and Point of Care Testing of Direct Oral Anticoagulants Subjects (PHAPOCU)

August 4, 2022 updated by: Job Harenberg, Doasense GmbH

Study on the Pharmacokinetics and Point of Care Testing After a Single Dose of 150 mg Dabigatran, 20 mg Rivaroxaban, 5 mg Apixaban, and 60 mg Edoxaban in Healthy Male Subjects

DOACs are increasingly used since 8 years. Standard coagulation tests (Prothrombin time [PT] and activated partial thromboplastin time [aPTT]) from plasma samples show a high variation. Special coagulation tests like hemoclot for dabigatran and chromogenic substrate assays for Rivaroxaban, Apixaban, and Edoxaban are time-consuming and can be performed only in specialized laboratories. In specific medical situations like in patients such as emergency procedures, stroke (before starting thrombolytic therapy), trauma, general surgery or other invasive procedures, it may be necessary for medical decision making to know the presence or absence of a DOAC in patient's body fluid. Until now there is no rapid, specific and sensitive coagulation test available in the market.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This prospective, open-label, controlled, not randomized trial in healthy volunteers to investigate comparatively the pharmacokinetics of the direct oral anticoagulants in plasma and in urine with LC-MS/MS and in urine by DOAC Dipstick.

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Mannheim, Germany, 68167
        • Clincial Research Serivces

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Fully signed and dated written informed consent

    • Age >18 years
    • healthy

Exclusion Criteria:

  • Patients not able to provide urine samples.

    • Patients not able to understand the informed consent or severe mentally disabled.
    • Patients in the end-stage of a severe disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Apixaban

Volunteers receive one oral dose of 5mg Apxiaban followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine.

Biological and clinical safety parameters are measured.
Drug: Apixaban 5 MG Tab
oral intake
Other Names:
  • Edoxaban, Dabigatran, rivaroxaban
ACTIVE_COMPARATOR: Dabigatran

Volunteers receive one oral dose of 150mg Dabigatran followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine.

Biological and clinical safety parameters are measured.
Drug: Dabigatran 150 MG Tab
oral intake
Other Names:
  • Apixaban, Edoxaban, Rivaroxaban
ACTIVE_COMPARATOR: Edoxaban

Volunteers receive one oral dose of 60mg Edoxaban followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine.

Biological and clinical safety parameters are measured.
Drug: Edoxaban 60Mg Tab
oral intake
Other Names:
  • Apixaban, Dabigatran, Rivaroxaban
ACTIVE_COMPARATOR: Rivaroxaban

Volunteers receive one oral dose of 20mg Rivaroxaban followed by sequential blood and urine sampling over 72 hours During the study liquid-chromatography mass-spectrometry analysis is performed in plasma and urine and DOAC Dipstick in urine.

Biological and clinical safety parameters are measured.
Drug: Rivaroxaban 20 MG Tab
oral intake
Other Names:
  • Apixaban, Edoxaban, Dabigatran

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy and specificity of the DOAC Dipstick compare to LC-MSMS
Time Frame: up to 6 months
Assess the accuracy and specificity of the IVD for oral direct factor Xa and thrombin inhibitors from urine samples of patients True positive and true negative rate of the point of care test (POCT) by comparison with the results obtained by bioanalytical quantification
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of qualitative POCT with quantitative LC-MS/MS
Time Frame: up to 6 months
Comparison of qualitative POCT with quantitative LC-MS/MS Investigator readings of POCT test results as compared to LC-MS/MS
up to 6 months
Questionnaire on handling and usability
Time Frame: up to 6 months
Specific questions to be answered using Lickert scale by personal performing the test
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Doasense GmbH

Investigators

  • Study Director: Armin Schultz, MD, Clinical Research Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2022

Primary Completion (ANTICIPATED)

December 30, 2023

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

February 11, 2019

First Submitted That Met QC Criteria

August 4, 2022

First Posted (ACTUAL)

August 8, 2022

Study Record Updates

Last Update Posted (ACTUAL)

August 8, 2022

Last Update Submitted That Met QC Criteria

August 4, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PhaKiDo-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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