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Healthy Volunteer StudyPhase 1PharmacoTXANCT03777488

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

A Phase 1 study testing Tranexamic Acid 1 gram intravenously, Tranexamic acid 2 grams oral solution and Tranexamic acid 1 gram intramuscular in people with Healthy Volunteer Study, run by London School of Hygiene and Tropical Medicine at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer Study
What is being tested?
Tranexamic Acid 1 gram intravenously, Tranexamic acid 2 grams oral solution and Tranexamic acid 1 gram intramuscular
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
2 sitesFrance
Study dates
30 Oct 2019to 14 Oct 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 12Show fewer
  • 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)

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • UFR Sciences de la Santé Simone Veil Université Versailles Saint Quentin en Yvelines

    Montigny-le-Bretonneux, 78180

  • Unité de Recherche Clinique Paris Descartes Necker Cochin, Hôpital Necker-Enfants Malades

    Paris, 75743

Other trials in France

About this study

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.

Read the 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
Being tested
Tranexamic Acid 1 gram intravenously, Tranexamic acid 2 grams oral solution, Tranexamic acid 1 gram intramuscular
Keywords
pharmacokinetics, tranexamic acid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic Acid 1 gram intravenouslyDrug

    Intravenous tranexamic acid crossover to oral and intramuscular arms

  • Tranexamic acid 2 grams oral solutionDrug

    Oral tranexamic acid crossover to intravenous and intramuscular arms

  • Tranexamic acid 1 gram intramuscularDrug

    Intramuscular tranexamic acid crossover to oral and intravenous arms

Study groups in NCT03777488
Study groupRoleWhat they receive
Tranexamic acid Group 1ExperimentalParticipants will receive tranexamic acid in the following order: First Dose: Intravenous Second Dose: Intramuscular Third Dose: Oral
Receives: Drug: Tranexamic Acid 1 gram intravenously; Drug: Tranexamic acid 2 grams oral solution; Drug: Tranexamic acid 1 gram intramuscular
Tranexamic acid Group 2ExperimentalParticipants will receive tranexamic acid in the following order: First Dose: Intravenous Second Dose: Oral Third Dose: Intramuscular
Receives: Drug: Tranexamic Acid 1 gram intravenously; Drug: Tranexamic acid 2 grams oral solution; Drug: Tranexamic acid 1 gram intramuscular
Tranexamic acid Group 3ExperimentalParticipants will receive tranexamic acid in the following order: First Dose: Intramuscular Second Dose: Intravenous Third Dose: Oral
Receives: Drug: Tranexamic Acid 1 gram intravenously; Drug: Tranexamic acid 2 grams oral solution; Drug: Tranexamic acid 1 gram intramuscular
Tranexamic acid Group 4ExperimentalParticipants will receive tranexamic acid in the following order: First Dose: Intramuscular Second Dose: Oral Third Dose: Intravenous
Receives: Drug: Tranexamic Acid 1 gram intravenously; Drug: Tranexamic acid 2 grams oral solution; Drug: Tranexamic acid 1 gram intramuscular
Tranexamic acid Group 5ExperimentalParticipants will receive tranexamic acid in the following order: First Dose: Oral Second Dose: Intravenous Third Dose: Intramuscular
Receives: Drug: Tranexamic Acid 1 gram intravenously; Drug: Tranexamic acid 2 grams oral solution; Drug: Tranexamic acid 1 gram intramuscular
Tranexamic acid Group 6ExperimentalParticipants will receive tranexamic acid in the following order: First Dose: Oral Second Dose: Intramuscular Third Dose: Intravenous
Receives: Drug: Tranexamic Acid 1 gram intravenously; Drug: Tranexamic acid 2 grams oral solution; Drug: Tranexamic acid 1 gram intramuscular

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum tranexamic acid concentrations versus time profiles for each route of administration (Oral, intramuscular and intravenous)

    Measured: 24 hours

Secondary outcomes (3)

  1. Pain during after administration (visual analogue scale) for each administration route

    (Scale 0 - 9) where 0 = no pain and 9 most severe pain

    Measured: 8 hours

  2. Reaction at site of injection for intramuscular and Iintravenous routes

    Measured: 24 hours

  3. • Correlation between serum and dry blood spot concentrations for each administration route

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Dec 2018
  2. Study start30 Oct 2019
  3. Primary completion14 Oct 2020
  4. Study completion14 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03777488
Sponsor's protocol ID
2018/KEP/205
Acronym
PharmacoTXA
Status last verified
Feb 2020
First submitted
13 Dec 2018
Last updated
18 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Grassin-Delyle S, Semeraro M, Lamy E, Urien S, Runge I, Foissac F, Bouazza N, Treluyer JM, Arribas M, Roberts I, Shakur-Still H. Pharmacokinetics of tranexamic acid after intravenous, intramuscular, and oral routes: a prospective, randomised, crossover trial in healthy volunteers. Br J Anaesth. 2022 Mar;128(3):465-472. doi: 10.1016/j.bja.2021.10.054. Epub 2022 Jan 5.

    PubMed 34998508

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tranexamic Acid 1 gram intravenously, Tranexamic acid 2 grams oral solution and Tranexamic acid 1 gram intramuscular in people with Healthy Volunteer Study, run by London School of Hygiene and Tropical Medicine at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Serum tranexamic acid concentrations versus time profiles for each route of administration (Oral, intramuscular and intravenous) (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03777488, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2020.

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