Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Subjects (Food Effect Study)
Condition: Healthy Adult Subjects
Intervention: MT-1186
Intervention description: A crossover study in which Japanese healthy subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 3, 5, 7 and 24 according to their treatment sequence.
Intervention MeSH terms: Edaravone
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      To evaluate the effect of food on the pharmacokinetics of oral edaravone in healthy adult
      subjects. In this study, we determined 5 different dietary conditions including 4 different
      meal contents and fasting condition.
    

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 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