A Clinical Trial to Evaluate the Effect of Grapefruit Juice on the PK/PD of Edoxaban

Launched by HYEWON CHUNG · Aug 1, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how drinking grapefruit juice might affect the way the body processes a medicine called edoxaban, which is used to prevent blood clots. The study will be done with healthy adults to understand if grapefruit juice changes how much of the medicine gets into the bloodstream and how it works.

To join the study, participants should be adults between 19 and 50 years old, with a healthy body weight, and generally in good health without serious medical conditions. People who have certain health problems, take specific medications, or have recently consumed grapefruit products won’t be eligible. Participants will be asked to agree to use birth control and provide written consent. During the trial, volunteers will likely be monitored closely to see how their bodies respond to edoxaban when combined with grapefruit juice. This information can help doctors know if it’s safe to drink grapefruit juice while taking this medicine.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adults aged 19 to 50 years of age (inclusive) at the time of screening
• • Subjects with BMI of 18 to 32 kg/m2 (inclusive)
• • Subjects who agree to use medically acceptable methods of contraception and not to donate sperm or oocyte
• • Subjects who voluntarily decided to participate in the study and provided written consent to comply with the protocol
• Exclusion Criteria:
• • Subjects with current or history of clinically significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunological, dermatological, or neuropsychiatric disease
• • Subjects with current or history of clinically significant hypersensitivity reactions or hypersensitivity reactions to the components or constituents of the investigational product
• • Subjects who have clinically significant hemorrhage or increased risk of hemorrhage due to the following conditions A. Recent history of gastrointesinal ulcers B. Malignant tumor with a high risk of bleeding C. Recent brain or spinal cord injury D. Recent brain, spinal cord, or opthalmic surgery E. Recent history of intracranial or intracerebral hemorrhage F. Esophageal varices, arterial malformations, vascular aneurysms, or spinal cord or cerebral vascular abnormalities G. Coagulation disorders, thrombocytopenia, or platelet dysfunction H. Recent biopsy or major trauma I. Bacterial endocarditis J. Esophagitis, Gastritis, or Gastroesophageal reflux
• • Subjects with a history of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• • Subjects whose eGFR calculated by the CKD-EPI formula is 80mL/min or less at Screening
• • Subjects whose AST or ALT levels are more than 2 times the upper limit of normal range, or total bilirubin levels are more than 1.5 times the upper limit of normal range at screening
• • Subjects whose coagulation test (aPTT, PT) exceeds the normal range at screening
• • Subjects who have taken the following medication or medication known to have significant drug interactions with the investigational product within the 2 weeks prior to the first administration day A. Strong P-gp inhibitor or inducer B. Acetylsalicylic acid, antiplatelet agent, anticoagulant, fibrinolytic agent, non-steroidal anti-inflammatory drug (NSAID), selective serotonin reuptake inhibitor (SSRI), or selective serotonin-norepinephrine reuptake inhibitor (SNRI)
• • Subjects who donated whole blood within 60 days or blood components within 30 days, or received blood transfusion within 30 days prior to the first administration day
• • Subjects who participated and have been exposed to an investigational product in other clinical study within 180 days prior to the first administration day
• • Subjects who consistently consumed alcohol (alcohol 21 units/week \[1 unit = 10 g of pure alcohol\]) within 2 weeks of the first administration day
• • Subjects who consumed grapefruit or grapefruit juice within 2 weeks of the first administration day
• • Pregnant or breastfeeding women
• • Subjects judged unsuitable to participate in the clinical study by investigators due to other reasons, including the results of laboratory tests