Pharmacokinetics of Tranexamic Acid After Oral, Intramuscular or Intravenous Administration: a Prospective, Randomised, Cross-over Trial in Healthy Volunteers.
PharmacoTXA
1 other identifier
interventional
15
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Oct 2019
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 13, 2018
CompletedFirst Posted
Study publicly available on registry
December 17, 2018
CompletedStudy Start
First participant enrolled
October 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 14, 2020
CompletedNovember 18, 2020
February 1, 2020
12 months
December 13, 2018
November 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum tranexamic acid concentrations versus time profiles for each route of administration (Oral, intramuscular and intravenous)
24 hours
Secondary Outcomes (3)
Pain during after administration (visual analogue scale) for each administration route
8 hours
Reaction at site of injection for intramuscular and Iintravenous routes
24 hours
• Correlation between serum and dry blood spot concentrations for each administration route
24 hours
Study Arms (6)
Tranexamic acid Group 1
EXPERIMENTALParticipants will receive tranexamic acid in the following order: First Dose: Intravenous Second Dose: Intramuscular Third Dose: Oral
Tranexamic acid Group 2
EXPERIMENTALParticipants will receive tranexamic acid in the following order: First Dose: Intravenous Second Dose: Oral Third Dose: Intramuscular
Tranexamic acid Group 3
EXPERIMENTALParticipants will receive tranexamic acid in the following order: First Dose: Intramuscular Second Dose: Intravenous Third Dose: Oral
Tranexamic acid Group 4
EXPERIMENTALParticipants will receive tranexamic acid in the following order: First Dose: Intramuscular Second Dose: Oral Third Dose: Intravenous
Tranexamic acid Group 5
EXPERIMENTALParticipants will receive tranexamic acid in the following order: First Dose: Oral Second Dose: Intravenous Third Dose: Intramuscular
Tranexamic acid Group 6
EXPERIMENTALParticipants will receive tranexamic acid in the following order: First Dose: Oral Second Dose: Intramuscular Third Dose: Intravenous
Interventions
Intravenous tranexamic acid crossover to oral and intramuscular arms
Oral tranexamic acid crossover to intravenous and intramuscular arms
Intramuscular tranexamic acid crossover to oral and intravenous arms
Eligibility Criteria
You may qualify if:
- 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
- Provision of signed informed consent prior to any study specific procedure
- People with public healthcare insurance (in France)
You may not qualify if:
- Previous thrombotic event or pre-existing pro-thrombotic disease
- Any history of seizures
- Any chronic or active cardiovascular or renal disease
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
UFR Sciences de la Santé Simone Veil Université Versailles Saint Quentin en Yvelines
Montigny-le-Bretonneux, 78180, France
Unité de Recherche Clinique Paris Descartes Necker Cochin, Hôpital Necker-Enfants Malades
Paris, 75743, France
Related Publications (1)
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.
PMID: 34998508DERIVED
Study Officials
- STUDY CHAIR
Haleema Shakur-Still
London School of Hygiene and Tropical Medicine
- STUDY CHAIR
Ian Roberts
London School of Hygiene and Tropical Medicine
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2018
First Posted
December 17, 2018
Study Start
October 30, 2019
Primary Completion
October 14, 2020
Study Completion
October 14, 2020
Last Updated
November 18, 2020
Record last verified: 2020-02