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

• Status: Completed
• Trial end date: 2020-10-14
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: London School of Hygiene and Tropical Medicine
• Treatments: Tranexamic Acid

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)