Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study)

Healthy Adult Subjects Clinical Trial

Official title:

Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04481789
• Other study ID #: MT-1186-J02
• Status: Completed
• Phase: Phase 1
• Start date: October 17, 2018
• Est. completion date: January 8, 2019

Study information

• Verified date: July 2020
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 the pharmacokinetics, safety, and tolerability of oral edaravone in healthy Japanese and Caucasian adult males

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: January 8, 2019
• Est. primary completion date: December 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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 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

• 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)

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Drug:
• MT-1186
Suspension
• Rosuvastatin
Tablets
• Sildenafil
Tablets
• Furosemide
Tablets

Locations

Country	Name	City	State
Japan	Investigational site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters - Area under the concentration versus time curve from time zero to infinity (AUC 0-inf) of rosuvastatin, sildenafil, furosemide, and unchanged edaravone, sulfate, glucuronide		Day 1 to 14 in group 1 of cohort 1, Day 1 to 8 in group 2 of cohort 1, Day 1 to 9 in cohort 2
Primary	PK parameters - Maximum plasma concentration (Cmax) of rosuvastatin, sildenafil, furosemide, and unchanged edaravone, sulfate, glucuronide		Day 1 to 14 in group 1 of cohort 1, Day 1 to 8 in group 2 of cohort 1, Day 1 to 9 in cohort 2
Primary	PK parameters - Time to reach maximum plasma concentration (tmax) of rosuvastatin, sildenafil, furosemide, and unchanged edaravone, sulfate, glucuronide		Day 1 to 14 in group 1 of cohort 1, Day 1 to 8 in group 2 of cohort 1, Day 1 to 9 in cohort 2
Primary	PK parameters - Terminal elimination half-life (t1/2) of rosuvastatin, sildenafil, furosemide, and unchanged edaravone, sulfate, glucuronide		Day 1 to 14 in group 1 of cohort 1, Day 1 to 8 in group 2 of cohort 1, Day 1 to 9 in cohort 2
Secondary	Number of Participants with Adverse events and adverse drug reactions		Day 1 to 20 in group 1 of cohort 1, Day 1 to 14 in group 2 of cohort 1, Day 1 to 14 of cohort 2