Grapefruit juice may alter blood thinner effects, small study hints
NCT ID NCT07113054
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This phase 1 trial in 14 healthy adults tests whether grapefruit juice changes how the body absorbs and processes the blood thinner edoxaban. Participants take edoxaban alone and then with grapefruit juice to compare drug levels and clotting measures. The goal is to see if grapefruit juice could make the drug more or less potent, which could affect safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- edoxaban and grapefruit juice
- What this could lead to
- If it works, this could help doctors understand whether grapefruit juice changes how the blood thinner edoxaban works in the body.
- What could go wrong
- This is a very small, early-phase study in healthy people, not patients. The results may not apply to everyone or lead to any change in medical advice.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 14 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2025
- Expected to finish
-
Oct 2025
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
19 to 50 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Korea University Guro Hospital
Seoul, Seoul, 08308, South Korea
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