Status:
COMPLETED
Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study)
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Healthy Adult Subjects
Eligibility:
MALE
20-45 years
Phase:
PHASE1
Brief Summary
* Cohort 1: To evaluate the drug interactions, safety, and tolerability of oral edaravone when coadministered with rosuvastatin, sildenafil or furosemide in healthy adult males * Cohort 2: To evaluate...
Eligibility Criteria
Inclusion
- Healthy adult male volunteers
- Cohort 1: Japanese, Cohort 2: 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
- Use of any drug(s) other than the study drug or as-needed use of acetylsalicylic acid within 7 days before the initiation of study drug or victim drug administration
- Use of any alcohol, xanthine, or caffeine-containing product(s) within 24 hours before screening and Day -1 visiting
- Use of any supplement(s) within 7 days before the initiation of study drug or victim drug administration
- Use of grapefruit, grapefruit juice, or any processed food(s) containing these substances during the following periods (Cohort 1: within 7 days before the initiation of victim drug administration, Cohort 2: within 24 hours before each Day -1 visiting)
- Use of any tobacco or nicotine-containing product(s) (Cohort 1: within 12 weeks before the initiation of victim drug administration during the following periods, Cohort 2: within 24 hours before each Day -1 visiting)
- Use of any health food(s) containing St John's Wort (Hypericum perforatum) within 2 weeks before the initiation of victim drug administration (only in Cohort 1)
Key Trial Info
Start Date :
October 17 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 8 2019
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT04481789
Start Date
October 17 2018
End Date
January 8 2019
Last Update
January 7 2026
Active Locations (1)
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1
Investigational site
Tokyo, Japan