Study of Oral Edaravone in Healthy Adult Males

• Status: Completed
• Trial end date: 2018-08-03
• Target enrollment: 0
• Participant gender: Male

Summary

To evaluate the pharmacokinetics safety, and tolerability of single and multiple doses of edaravone solution and suspension in healthy adult males

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

Details

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

Criteria

Inclusion Criteria:

Additional screening criteria check may apply for qualification:

• Healthy adult male volunteers

• Japanese or Caucasian

• Subjects aged between 20 and 45 years at the time of informed consent

• Subjects who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study

Exclusion Criteria:

Additional screening criteria check may apply for qualification:

• 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

• Body mass index (BMI) of <18.0 or >30.0, or body weight of <50 kg (BMI formula: body weight [kg]/height [m]2, rounded to one decimal place)

• Subjects who have undergone any surgery known to affect the gastrointestinal absorption of drugs

• Subjects who do not agree to use an effective method of contraception from initiation of study drug administration to 14 days after completion (discontinuation) of study drug administration

• Subjects who have previously received edaravone

• Subjects who have participated in another clinical study and received a study drug within 12 weeks before providing informed consent