PRIVAG Pk study assessing interaction between apixaban and rivaroxaban
Research type
Research Study
Full title
A pharmacokinetic assessment of the potential interaction of rivaroxaban and apixaban with grapefruit juice in healthy adult male and female participants
IRAS ID
350348
Contact name
Michalis Kostapanos
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust
Duration of Study in the UK
0 years, 5 months, 30 days
Research summary
Grapefruit juice (GFJ) is known to interact with many medications, including those broken down by the intestinal enzyme CYP3A4. GFJ contains two compounds, 6,7-Dihydroxybergamottin and bergamottin, which block this enzyme and can cause drug levels in the blood to rise significantly. For example, studies have shown increases of 1.5 to 15 times in drugs like statins and calcium channel blockers.
Direct oral anticoagulants (DOACs), such as apixaban and rivaroxaban, are widely used blood thinners that are marketed as fixed-dose medications without the need for routine blood tests. However, some doctors and researchers believe DOAC levels should be monitored in certain situations, like when interacting with other drugs or foods. GFJ is a commonly consumed beverage, but no human studies have examined its effects on DOACs. Combining GFJ with DOACs may increase the risk of serious side effects, such as bleeding.
This study will investigate whether apixaban and rivaroxaban can be safely taken with GFJ. Healthy volunteers will receive a single dose of each DOAC with or without GFJ during separate treatment periods lasting three days. A washout period between treatments will ensure the drugs are cleared from the body. Since only one dose of a DOAC is given, the risk of bleeding is very low. Participants will have regular safety tests to monitor for any issues.
The findings of this study will help determine if GFJ significantly alters the safety or effectiveness of these medications. Based on the results, patient information leaflets may be updated to provide clear guidance and prevent unnecessary side effects.
REC name
West of Scotland REC 5
REC reference
25/WS/0042
Date of REC Opinion
25 Apr 2025
REC opinion
Further Information Favourable Opinion