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

Healthy Volunteer Study Clinical Trial

— PharmacoTXA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03777488
• Other study ID #: 2018/KEP/205
• Status: Completed
• Phase: Phase 1
• Start date: October 30, 2019
• Est. completion date: October 14, 2020

Study information

• Verified date: February 2020
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. It will also determine the feasibility of measuring tranexamic acid in spots of dry capillary blood.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 14, 2020
• Est. primary completion date: October 14, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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 ß-human chorionic gonadotropin (ßhCG) 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)

Related Conditions & MeSH terms

• Healthy Volunteer Study

Intervention

Drug:
• Tranexamic Acid 1 gram intravenously
Intravenous tranexamic acid crossover to oral and intramuscular arms
• Tranexamic acid 2 grams oral solution
Oral tranexamic acid crossover to intravenous and intramuscular arms
• Tranexamic acid 1 gram intramuscular
Intramuscular tranexamic acid crossover to oral and intravenous arms

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum tranexamic acid concentrations versus time profiles for each route of administration (Oral, intramuscular and intravenous)		24 hours
Secondary	Pain during after administration (visual analogue scale) for each administration route	(Scale 0 - 9) where 0 = no pain and 9 most severe pain	8 hours
Secondary	Reaction at site of injection for intramuscular and Iintravenous routes		24 hours
Secondary	• Correlation between serum and dry blood spot concentrations for each administration route		24 hours