Pharmacokinetics of Tranexamic Acid: a randomised trial in healthy volunteers.

Pharmacokinetics of Tranexamic Acid after oral, intramuscular or intravenous administration: a prospective, randomised, cross-over trial in healthy volunteers. - PharmacoTXA

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000285-38-FR

Enrollment

Registered

2019-04-09

Start date

2019-08-21

Completion date

Unknown

Last updated

2020-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

healthy volunteers

Interventions

Trade Name: Exacyl® (Sanofi Aventis) 0.5 g/5 ml injectable solution IV Product Name: EXACYL Pharmaceutical Form: Solution for injection INN or Proposed INN: acide 4-(méthylamino)cyclohexanecarboxyliqu

Eligibility

Sex/Gender

All

Inclusion 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 limits: fibrinogen [ 1.5 - 3.5 g/L] D-dimers 70 % partial thromboplastin time =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 • Visual disturbance • Haematuria • Known allergy or contraindication 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: - Patient deprived of liberty by judicial or administrative decision - Adult protected by law

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the pharmacokinetics of tranexamic acid in healthy volunteers using a population approach after oral, intramuscular or intravenous administration;Secondary Objective: To evaluate the local and systemic safety profile with the different routes of administration. To determine the feasibility of measuring tranexamic acid in dry blood spots ;Primary end point(s): • Serum tranexamic acid concentrations versus time profiles for each route of administration.;Timepoint(s) of evaluation of this end point: 24 hrs after each administration	—

Measure

Time frame

Main Objective: To determine the pharmacokinetics of tranexamic acid in healthy volunteers using a population approach after oral, intramuscular or intravenous administration;Secondary Objective: To evaluate the local and systemic safety profile with the different routes of administration. To determine the feasibility of measuring tranexamic acid in dry blood spots ;Primary end point(s): • Serum tranexamic acid concentrations versus time profiles for each route of administration.;Timepoint(s) of evaluation of this end point: 24 hrs after each administration

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Secondary

Measure	Time frame
Secondary end point(s): • Average pain score and duration of pain after administration (visual analogue scale) for each administration route at visits V1, V3, V5 • Reaction at site of injection (redness, swelling, induration, tenderness, ecchymosis, necrosis, nerve injury, infection) for IM and IV administration route at visits V1, V2, V3, V4, V5, V6 • Vital signs (blood pressure, heart rate and respiratory rate) after administration for each administration route at visits V1, V2, V3, V4, V5, V6 • Solicited adverse events (fever, nausea, vomiting, diarrhoea, visual impairment, seizure) • Number of participants with solicited local and systemic adverse events • Number of participants reporting one or more adverse events and serious adverse events • Correlation between serum and dry blood spot concentrations for each administration route at visits V1, V3, V5;Timepoint(s) of evaluation of this end point: 24 hrs after each administration	—

Measure

Time frame

Secondary end point(s): • Average pain score and duration of pain after administration (visual analogue scale) for each administration route at visits V1, V3, V5 • Reaction at site of injection (redness, swelling, induration, tenderness, ecchymosis, necrosis, nerve injury, infection) for IM and IV administration route at visits V1, V2, V3, V4, V5, V6 • Vital signs (blood pressure, heart rate and respiratory rate) after administration for each administration route at visits V1, V2, V3, V4, V5, V6 • Solicited adverse events (fever, nausea, vomiting, diarrhoea, visual impairment, seizure) • Number of participants with solicited local and systemic adverse events • Number of participants reporting one or more adverse events and serious adverse events • Correlation between serum and dry blood spot concentrations for each administration route at visits V1, V3, V5;Timepoint(s) of evaluation of this end point: 24 hrs after each administration

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Countries

France

Contacts

Public ContactFlorence Favrel-Feuillade

Assistance Publique Hôpitaux de Paris

christophe.aucan@aphp.fr33144841709

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 13, 2026