An Open Label, Non-Randomised, Phase IV Clinical Trial to Determine the Transfer of Apixaban and Rivaroxaban in Breast Milk Following Oral Administratio

Phase 1

• Conditions: healthy volunteers (Venous Thromboembolism); MedDRA version: 20.0Level: LLTClassification code 10049909Term: Venous thromboembolism prophylaxisSystem Organ Class: 100000004865; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2018-003852-19-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-18
• Last Update Posted: 7 September 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 4

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 <90 micro mol/L. Normal liver function tests – results of the serum ALT 9. Women are not taking any medication interacting with apixaban or rivaroxaban, as listed in table 6.4 and 6.5.
10. Women are available to attend scheduled visits at clinical unit and permit the clinic staffs visit home to collect blood and milk samples.
11. Women agree to the study restrictions

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified