Study of Oral Edaravone in Healthy Adult Males

Healthy Adult Subjects Clinical Trial

Official title:

Phase I Study of Oral Edaravone in Healthy Adult Males (Single- and Multiple-dose Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04481750
• Other study ID #: MT-1186-J01
• Status: Completed
• Phase: Phase 1
• Start date: March 20, 2018
• Est. completion date: August 3, 2018

Study information

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

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: August 3, 2018
• Est. primary completion date: August 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Adult Subjects

Intervention

Drug:
• MT-1186
Solution or suspension
• MT-1186-matching placebo
Solution or suspension

Locations

Country	Name	City	State
Japan	Investigational Site	Osaka

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	Number of Participants with Adverse events and adverse drug reactions		Day 1 to 8 in part 1, day1 to 12 in part 2
Primary	Plasma concentrations	Plasma concentrations of unchanged edaravone, sulfate, and glucuronide for PK analysis	Day 1 to 3 in part 1, day 1 to 7 in part 2
Primary	PK parameters - Area under the concentration versus time curve (AUC) of unchanged edaravone, sulfate, and glucuronide	AUC from time zero to the last measured time point (AUC 0-last), AUC from time zero to 12 hours (AUC 0-12), from time zero to 24 hours (AUC 0-24), and AUC from time zero to infinity (AUC 0-inf)	Day 1 to 3 in part 1, day 1 to 7 in part 2
Primary	PK parameters - Maximum plasma concentration (Cmax) of unchanged edaravone, sulfate, and glucuronide		Day 1 to 3 in part 1, day 1 to 7 in part 2
Primary	PK parameters - Minimum plasma concentration (Ctrough) of unchanged edaravone, sulfate, and glucuronide		Day 1 to 7 in part 2
Primary	PK parameters - Time to reach maximum plasma concentration (tmax) of unchanged edaravone, sulfate, and glucuronide		Day 1 to 3 in part 1, day 1 to 7 in part 2
Primary	PK parameters - Terminal elimination half-life (t1/2) of unchanged edaravone, sulfate, and glucuronide		Day 1 to 3 in part 1, day 1 to 7 in part 2
Primary	PK parameters - Lambda-z of unchanged edaravone, sulfate, and glucuronide		Day 1 to 3 in part 1, day 1 to 7 in part 2
Primary	PK parameters - Mean residence time (MRT) of unchanged edaravone		Day 1 to 3 in part 1, day 1 to 7 in part 2
Primary	PK parameters - Apparent total clearance (CL/F) of unchanged edaravone		Day 1 to 3 in part 1, day 1 to 7 in part 2
Primary	PK parameters - Apparent distribution volume at elimination phase (Vz/F) of unchanged edaravone		Day 1 to 3 in part 1, day 1 to 7 in part 2
Primary	PK parameters - Apparent distribution volume at steady state (Vss/F) of unchanged edaravone		Day 1 to 3 in part 1, day 1 to 7 in part 2
Secondary	Heart rate		Day 1 to 3 in cohort 4, 5 and 6 in part 1
Secondary	PR interval		Day 1 to 3 in cohort 4, 5 and 6 in part 1
Secondary	QT interval		Day 1 to 3 in cohort 4, 5 and 6 in part 1
Secondary	QTcF		Day 1 to 3 in cohort 4, 5 and 6 in part 1
Secondary	QRS interval		Day 1 to 3 in cohort 4, 5 and 6 in part 1