Grapefruit juice may alter blood thinner effects, small study hints

NCT ID NCT07113054

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Korea University Guro Hospital

    Seoul, Seoul, 08308, South Korea

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