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Pharmacokinetics of Tranexamic Acid After Oral, Intramuscular or Intravenous Administration: a Prospective, Randomised, Cross-over Trial in Healthy Volunteers. (PharmacoTXA)

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: NCT03777488
Recruitment Status : Completed
First Posted : December 17, 2018
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

Study Description
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Brief Summary:
This is a Phase 1 study which aims to determine the pharmacokinetics and local and systemic tolerance of tranexamic acid in healthy volunteers using a population approach after oral, intramuscular or intravenous administration. It will also determine the feasibility of measuring tranexamic acid in spots of dry capillary blood.

Condition or disease Intervention/treatment Phase
Healthy Volunteer Study Drug: Tranexamic Acid 1 gram intravenously Drug: Tranexamic acid 2 grams oral solution Drug: Tranexamic acid 1 gram intramuscular Phase 1

Detailed Description:

Fifteen healthy volunteers will receive in random order 1 gram of intravenous and intramuscular injections and 2 grams of oral tranexamic acid solution. Blood samples will be taken at:

  • T0+ 5min (only for IV route)
  • T0+30min
  • T0+1h
  • T0+2h
  • T0+3h
  • T0+4h
  • T0+5h
  • T0+6h
  • T0+8h (only for IM and PO routes)
  • T0+24h
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Pharmacokinetics of Tranexamic Acid After Oral, Intramuscular or Intravenous Administration: a Prospective, Randomised, Cross-over Trial in Healthy Volunteers.
Actual Study Start Date : October 30, 2019
Actual Primary Completion Date : October 14, 2020
Actual Study Completion Date : October 14, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Tranexamic acid Group 1

Participants will receive tranexamic acid in the following order:

First Dose: Intravenous Second Dose: Intramuscular Third Dose: Oral

 Drug: Tranexamic Acid 1 gram intravenously
Intravenous tranexamic acid crossover to oral and intramuscular arms

Drug: Tranexamic acid 2 grams oral solution
Oral tranexamic acid crossover to intravenous and intramuscular arms

Drug: Tranexamic acid 1 gram intramuscular
Intramuscular tranexamic acid crossover to oral and intravenous arms
Experimental: Tranexamic acid Group 2

Participants will receive tranexamic acid in the following order:

First Dose: Intravenous Second Dose: Oral Third Dose: Intramuscular

 Drug: Tranexamic Acid 1 gram intravenously
Intravenous tranexamic acid crossover to oral and intramuscular arms

Drug: Tranexamic acid 2 grams oral solution
Oral tranexamic acid crossover to intravenous and intramuscular arms

Drug: Tranexamic acid 1 gram intramuscular
Intramuscular tranexamic acid crossover to oral and intravenous arms
Experimental: Tranexamic acid Group 3

Participants will receive tranexamic acid in the following order:

First Dose: Intramuscular Second Dose: Intravenous Third Dose: Oral

 Drug: Tranexamic Acid 1 gram intravenously
Intravenous tranexamic acid crossover to oral and intramuscular arms

Drug: Tranexamic acid 2 grams oral solution
Oral tranexamic acid crossover to intravenous and intramuscular arms

Drug: Tranexamic acid 1 gram intramuscular
Intramuscular tranexamic acid crossover to oral and intravenous arms
Experimental: Tranexamic acid Group 4

Participants will receive tranexamic acid in the following order:

First Dose: Intramuscular Second Dose: Oral Third Dose: Intravenous

 Drug: Tranexamic Acid 1 gram intravenously
Intravenous tranexamic acid crossover to oral and intramuscular arms

Drug: Tranexamic acid 2 grams oral solution
Oral tranexamic acid crossover to intravenous and intramuscular arms

Drug: Tranexamic acid 1 gram intramuscular
Intramuscular tranexamic acid crossover to oral and intravenous arms
Experimental: Tranexamic acid Group 5

Participants will receive tranexamic acid in the following order:

First Dose: Oral Second Dose: Intravenous Third Dose: Intramuscular

 Drug: Tranexamic Acid 1 gram intravenously
Intravenous tranexamic acid crossover to oral and intramuscular arms

Drug: Tranexamic acid 2 grams oral solution
Oral tranexamic acid crossover to intravenous and intramuscular arms

Drug: Tranexamic acid 1 gram intramuscular
Intramuscular tranexamic acid crossover to oral and intravenous arms
Experimental: Tranexamic acid Group 6

Participants will receive tranexamic acid in the following order:

First Dose: Oral Second Dose: Intramuscular Third Dose: Intravenous

 Drug: Tranexamic Acid 1 gram intravenously
Intravenous tranexamic acid crossover to oral and intramuscular arms

Drug: Tranexamic acid 2 grams oral solution
Oral tranexamic acid crossover to intravenous and intramuscular arms

Drug: Tranexamic acid 1 gram intramuscular
Intramuscular tranexamic acid crossover to oral and intravenous arms


Outcome Measures
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Primary Outcome Measures :
  1. Serum tranexamic acid concentrations versus time profiles for each route of administration (Oral, intramuscular and intravenous) [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Pain during after administration (visual analogue scale) for each administration route [ Time Frame: 8 hours ]
    (Scale 0 - 9) where 0 = no pain and 9 most severe pain

  2. Reaction at site of injection for intramuscular and Iintravenous routes [ Time Frame: 24 hours ]
  3. • Correlation between serum and dry blood spot concentrations for each administration route [ Time Frame: 24 hours ]

Eligibility Criteria
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Information from the National Library of Medicine

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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:

  • Adult healthy volunteers both men and non-pregnant women
  • ≥18-≤45-year-old
  • Body mass index between ≥18 and ≤30 kg/m2, and bodyweight between ≥50 and ≤100 kg
  • Coagulation test results of fibrinogen, D-dimers, prothrombin time and a partial thromboplastin time within normal limits at screening
  • Normal renal function based on medical history and laboratory tests
  • If a woman, must have a negative urine β-human chorionic gonadotropin (βhCG) pregnancy test at screening and inclusion visits
  • Provision of signed informed consent prior to any study specific procedure
  • People with public healthcare insurance (in France)

Exclusion Criteria:

  • Previous thrombotic event or pre-existing pro-thrombotic disease
  • Any history of seizures
  • Any chronic or active cardiovascular or renal disease
  • Planned general anaesthesia or surgery in the 3 months following inclusion
  • Pregnant and/or breastfeeding
  • Known allergy to the study drugs or any of the excipients of the formulations
  • Use of any prescription or non-prescription medication (other than hormonal contraception) within 7 days before the first dose of the study drug is scheduled
  • Inability to give informed consent
  • Previous participation during the year in clinical studies compensated for an amount incompatible with participation in this study, verified by recording in the national register of subjects participating in human research trials

  • Legal criteria:

    • People deprived of liberty by judicial or administrative decision
    • Adult protected by law (France)
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): NCT03777488


Locations
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France
UFR Sciences de la Santé Simone Veil Université Versailles Saint Quentin en Yvelines
Montigny-Le-Bretonneux, France, 78180
Unité de Recherche Clinique Paris Descartes Necker Cochin, Hôpital Necker-Enfants Malades
Paris, France, 75743
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Investigators
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Study Chair: Haleema Shakur-Still LSHTM
Study Chair: Ian Roberts LSHTM
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT03777488    
Other Study ID Numbers: 2018/KEP/205
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by London School of Hygiene and Tropical Medicine:
pharmacokinetics, tranexamic acid
Additional relevant MeSH terms:
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Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
 Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants