Status:
COMPLETED
Study of Oral Edaravone in Healthy Adult Males
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Healthy Adult Subjects
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
To evaluate the pharmacokinetics safety, and tolerability of single and multiple doses of edaravone solution and suspension in healthy adult males
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 20 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2018
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04481750
Start Date
March 20 2018
End Date
August 3 2018
Last Update
January 7 2026
Active Locations (1)
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1
Investigational Site
Osaka, Japan