healthy volunteers (Venous Thromboembolism) MedDRA version: 20.0 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Xarelto
Product Name: Rivaroxaban
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: RIVAROXABAN
CAS Number: 366789-02-8
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
King's College London
King's College Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subject is informed and given ample time and opportunity to think about his/her participation and has provided written informed consent for participation in the study before any study specific procedures take place. 2. Subject is considered reliable and capable of adhering to applicable protocol requirements, including the study drug being administered orally and visit schedule according to the judgement of the Investigator. 3. Women are aged =18 years. 4. At least 6 weeks postpartum when enter the study. 5. Decision has been confirmed by the woman to stop breastfeeding their baby soon. 6. Negative pregnancy test. 7. Good physical and mental health, in the opinion of the Investigator, determined on the basis of medical history and general clinical examination at Screening. 8. Women have clinical laboratory test results within the reference ranges of the testing laboratory: normal renal function test – results of the serum creatinine =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Women who are unable to provide written informed consent. 2. LMWH thromboprophylaxis is indicated. 3. Increased risk of bleeding for any reason. 4. Known contra-indications to apixaban or rivaroxaban. 5. On-going treatment with aspirin, NSAIDs or other drugs that affect haemostasis. 6. Treatment with oral ketoconazole or itraconazole, medicines to treat fungal infections. 7. Patients who have received an artificial heart valve, have had a heart attack or suffer an irregular heartbeat (including taking dronedarone). 8. Known impaired renal function (serum creatinine > 90 micro mol/L). 9. Known abnormal liver function tests (ALT > 40 IU/L). 10. Known hypersensitivity or allergy to apixaban or rivaroxaban. 11. Use of other investigational study drugs within 30 days prior to study entry. 12. Women who are pregnant or of childbearing potential who refuse to use an acceptable effective form of contraception throughout the study. 13. Women who will not participate in study visits within a suitable distance from King’s College Hospital NHS Foundation Trust, as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine if apixaban and rivaroxaban are excreted in breastmilk following single dose oral administration to breastfeeding mothers. ;Secondary Objective: To evaluate the concentration-time profiles of apixaban and rivaroxaban in the plasma and breastmilk of breastfeeding mothers, and therefore to establish the potential exposure of breastfed infants to apixaban and rivaroxaban;Primary end point(s): Apixaban and its metabolites in plasma and breast milk will be measured at 0, 3-4, 7, 12, 14, 16, 24 hours after swallowing two 5mg capsules of apixaban (1 capsule 12 hours apart). Rivaroxaban in plasma and breast milk will be measured at 0, 2-3, 6, 10, 12, 24 hours after swallowing one 20mg tablet of rivaroxaban. Milk sampling from both breasts will be done at each time point. ;Timepoint(s) of evaluation of this end point: Apixaban and its metabolites in plasma and breast milk will be measured at 0, 3-4, 7, 12, 14, 16, 24 hours after swallowing two 5mg capsules of apixaban (1 capsule 12 hours apart). Rivaroxaban in plasma and breast milk will be measured at 0, 2-3, 6, 10, 12, 24 hours after swallowing one 20mg tablet of rivaroxaban. Milk sampling from both breasts will be done at each time point. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following PK parameters for apixaban and rivaroxaban in milk and plasma will be the endpoints: Area under the concentration-time curve (AUC) from zero to the time of the last quantifiable concentration (AUC(0-t)); AUC from zero to the time of 24 hours (AUC(0-24)).;Timepoint(s) of evaluation of this end point: 0 to 24 hours | — |
Countries
United Kingdom
Contacts
Public ContactRoopen Arya
King's College London
Outcome results
None listed