Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Subjects (Food Effect Study)

• Status: Completed
• Trial end date: 2019-07-24
• Target enrollment: 0
• Participant gender: All

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 diffrerent meal contents and fasting condition.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation
• Treatments: Edaravone

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