Comparative Bioavailability Study of Oral Edaravone Administered Orally and Via a Nasogastric Tube
Condition: Healthy Adult Subjects
Intervention: MT-1186
Intervention description: Suspension
Intervention MeSH terms: Edaravone
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To investigate the comparative bioavailability of edaravone oral suspension administered
      orally and via a nasogastric tube in healthy adult subjects
    

Eligibility criteria:

        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 meet any of the following criteria between screening and
        investigational product administration will be 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 antigen,
             serological test for syphilis, hepatitis C virus antibody, or human immunodeficiency
             virus antigen/antibody, subject has a positive COVID-19 virus test on Day -1

          6. Any clinically significant 12-lead ECG abnormality or 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, or blood donation and transfusion from informed consent to the start of
             investigational product administration

          9. Subjects who have undergone any surgery known to affect the gastrointestinal
             absorption of drugs (except for appendectomy and herniotomy)

         10. Female subjects of childbearing potential 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 alcohol or any products containing xanthin or caffeine within 24 hours before
             screening and visit on Day -1

         15. Use of any nutritional supplement(s) within 7 days before the initiation of
             investigational product administration

         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 with a history of reconstructive nasal surgery, or any evidence of
             deformities or asymmetry of the nose, non-patent nares/obstructed nasal airway, or the
             presence of nasal ulcers or polyps that would prevent an adequate NGT insertion.

         20. Subjects judged by the investigator (or subinvestigator) to be unsuitable for the
             study for any other reason