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

November 17, 2020 updated by: London School of Hygiene and Tropical Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

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

  • France
      • Montigny-Le-Bretonneux, France, 78180
        • UFR Sciences de la Santé Simone Veil Université Versailles Saint Quentin en Yvelines
      • Paris, France, 75743
        • Unité de Recherche Clinique Paris Descartes Necker Cochin, Hôpital Necker-Enfants Malades

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 to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

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: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum tranexamic acid concentrations versus time profiles for each route of administration (Oral, intramuscular and intravenous)
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 hours
Reaction at site of injection for intramuscular and Iintravenous routes
Time Frame: 24 hours
24 hours
• Correlation between serum and dry blood spot concentrations for each administration route
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

London School of Hygiene and Tropical Medicine

Investigators

  • Study Chair: Haleema Shakur-Still, LSHTM
  • Study Chair: Ian Roberts, LSHTM

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)

October 30, 2019

Primary Completion (ACTUAL)

October 14, 2020

Study Completion (ACTUAL)

October 14, 2020

Study Registration Dates

First Submitted

December 13, 2018

First Submitted That Met QC Criteria

December 13, 2018

First Posted (ACTUAL)

December 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 17, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/KEP/205

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.

Clinical Trials on Healthy Volunteer Study

Clinical Trials on Tranexamic Acid 1 gram intravenously

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe