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Study of Oral Edaravone in Healthy Adult Males

CompletedPhase 1

Sponsor: Shionogi

Conditions: Healthy Adult Subjects

Interventions: MT-1186, MT-1186-matching placebo

Countries: Japan

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

Eligibility overview

Sex: MALE

Age: 20 Years to 45 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility 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

Locations (1)

Osaka, Japan