Healthy Volunteer Study
Conditions
Keywords
pharmacokinetics, tranexamic acid
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.
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
Interventions
DRUGTranexamic Acid 1 gram intravenously
Intravenous tranexamic acid crossover to oral and intramuscular arms
DRUGTranexamic acid 2 grams oral solution
Oral tranexamic acid crossover to intravenous and intramuscular arms
DRUGTranexamic acid 1 gram intramuscular
Intramuscular tranexamic acid crossover to oral and intravenous arms
Sponsors
London School of Hygiene and Tropical Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum tranexamic acid concentrations versus time profiles for each route of administration (Oral, intramuscular and intravenous) | 24 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Pain during after administration (visual analogue scale) for each administration route | 8 hours | (Scale 0 - 9) where 0 = no pain and 9 most severe pain |
Countries
France
Outcome results
None listed