Meal timing matters: study tests edaravone absorption after different foods
NCT ID NCT05342597
First seen Jun 27, 2026 · Last updated Jul 16, 2026 · Updated 2 times
Summary
This study looked at how eating different types of meals affects the way the body absorbs oral edaravone, a medication used for ALS. Sixteen healthy Japanese adults took the drug under five different dietary conditions, including fasting. The goal was to understand how food changes drug levels in the blood and urine, which helps guide dosing instructions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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16 people
The number who actually took part.
- Started
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Jun 2019
- Finished
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Jul 2019
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Subjects who meet all of the following criteria and who have the capability of giving informed consent will be included in the study. 1. Healthy adult male or female volunteers 2. Japanese 3. Subjects aged between 20 and 45 years at the time of informed consent 4. Subjects who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study Exclusion Criteria: * Subjects who met any of the following exclusion criteria between screening and investigational product administration were excluded from the study: 1. Subjects with a current or previous history of cardiac, hepatic, renal, gastrointestinal, respiratory, psychiatric/nervous, hematopoietic, or endocrine diseases, and those whom the investigator (or subinvestigator) deems unsuitable for the study 2. History of drug or food allergies 3. History of alcohol or drug abuse or dependence 4. Body mass index (BMI) of \< 18.0 or \> 30.0, or a body weight of \< 50 kg \[BMI formula: body weight (kg)/height (m)2, rounded to one decimal place\] 5. Positive test for any of the following at screening: hepatitis B surface (HBs) antigen, serological test for syphilis, hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen/antibody 6. Any clinically significant 12-lead ECG abnormality or corrected QT interval (QTc) using Fridericia's formula (QTcF) interval ≥ 450 msec 7. Blood donation or sampling with a total volume of ≥ 400 mL within 12 weeks, ≥ 200 mL within 4 weeks, or ≥ 800 mL within one year before providing informed consent 8. Blood component donation or blood sampling within 2 weeks before providing informed consent 9. Subjects who have undergone any surgery known to affect the gastrointestinal absorption of drugs (except for appendectomy and herniotomy) 10. Female subjects who do not agree to use an effective method of contraception from screening or 2 weeks before the start of investigational product administration, whichever comes earlier, to 14 days after the completion (or discontinuation) of investigational product administration. Male subjects who do not agree to use an effective method of contraception from the start of investigational product administration to 14 days after the completion (or discontinuation) of investigational product administration 11. Subjects who have previously received edaravone 12. Subjects who have participated in another clinical study and received an investigational product within 12 weeks before providing informed consent 13. Subjects who have used any drugs other than the single use of acetylsalicylic acid within 7 days before the initiation of investigational product administration 14. Use of any nutritional supplement(s) within 7 days before the initiation of investigational product administration 15. Use of alcohol or any products containing xanthin or caffeine within 24 hours before screening and visit on Day -1 16. Use of grapefruit, grapefruit juice, or any processed food(s) containing these substances within 24 hours before screening and visit on Day -1 17. Use of any tobacco or nicotine-containing product(s) within 24 hours before screening and visit on Day -1 18. Female subjects who have a positive pregnancy test at screening and on Day -1, are pregnant or breast feeding, or plan to get pregnant during the study 19. Subjects judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason
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Genom att skicka in godkänner du våra Användarvillkor
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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Investigational site
Tokyo, Japan
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Other studies related to the condition(s) this trial covers.
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