Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects

• Sponsor: Mitsubishi Tanabe Pharma Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04493281
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.6
• Patients Per Site Per Month: 26.6

Study Details

Study Description

Brief Summary

To evaluate the single-dose bioequivalence of oral suspension and intravenous (IV) formulation of edaravone in the fasting state in healthy adult subjects

Condition or Disease	Intervention/Treatment	Phase
Healthy Adult Subjects	Drug: MT-1186; Drug: MCI-186	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Bioequivalence Study of Oral Suspension and Intravenous Formulation of Edaravone in Healthy Adult Subjects
• Actual Study Start Date: Mar 22, 2019
• Actual Primary Completion Date: Apr 21, 2019
• Actual Study Completion Date: May 9, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MT-1186 Healthy subjects were administered a single dose of Edaravone oral suspension	Drug: MT-1186; Oral suspension; Other Names: Edaravone
Active Comparator: MCI-186 Healthy subjects were administered a single dose of Edaravone intravenous formulation	Drug: MCI-186; Intravenous formulation; Other Names: Edaravone

Outcome Measures

Primary Outcome Measures

1. PK parameters - Area under the plasma concentration versus time curve from time zero up to the last quantifiable concentration time-point (AUC0-t) of unchanged edaravone after oral and intravenous administration [Day 1 to 2]

2. PK parameters - Area under the plasma concentration versus time curve from time zero up to infinity with extrapolation of the terminal phase (AUC0-inf) of unchanged edaravone after oral and intravenous administration [Day 1 to 2]

3. PK parameters - Maximum plasma concentration (Cmax) of unchanged edaravone after oral and intravenous administration [Day 1 to 2]

Secondary Outcome Measures

1. PK parameters - Area under the plasma concentration versus time curve from time zero up to 24 hours (AUC0-24) of unchanged edaravone, sulfate, and glucuronide conjugates after oral and intravenous administration [Day 1 to 2]

2. PK parameters - Area under the plasma concentration versus time curve from time zero up to the last sampling time-point (for all time-points) (AUC0-all) of unchanged edaravone, sulfate, and glucuronide conjugates after oral and intravenous administration [Day 1 to 2]

3. PK parameters - Time to reach maximum plasma concentration (tmax) of unchanged edaravone, sulfate, and glucuronide conjugates after oral and intravenous administration [Day 1 to 2]

4. PK parameters - Terminal elimination half-life (t1/2) of unchanged edaravone, sulfate, and glucuronide conjugates after oral and intravenous administration [Day 1 to 2]

5. PK parameters - Elimination rate constant from the central compartment (Kel) of unchanged edaravone, sulfate, and glucuronide conjugates after oral and intravenous administration [Day 1 to 2]

6. PK parameters - Mean residence time (MRT) of unchanged edaravone after oral and intravenous administration [Day 1 to 2]

7. PK parameters - Total clearance (CL) of unchanged edaravone after intravenous administration [Day 1 to 2]

8. PK parameters - Volume of distribution during terminal phase (Vz) of unchanged edaravone after intravenous administration [Day 1 to 2]

9. PK parameters -Volume of distribution at steady state (Vss) of unchanged edaravone after intravenous administration [Day 1 to 2]

10. PK parameters - Apparent total clearance (CL/F) of unchanged edaravone after oral administration [Day 1 to 2]

11. PK parameters - Apparent volume of distribution during terminal phase (Vz/F) of unchanged edaravone after oral administration [Day 1 to 2]

12. PK parameters - Apparent volume of distribution at steady state (Vss/F) of unchanged edaravone after oral administration [Day 1 to 2]

13. PK parameters -Cumulative amount of drug excreted in urine (Ae) of unchanged edaravone, sulfate, and glucuronide conjugates after oral and intravenous administration [Day 1 to 2]

14. PK parameters - Cumulative percentage of drug excreted in urine (Ae%) of unchanged edaravone, sulfate, and glucuronide conjugates after oral and intravenous administration [Day 1 to 2]

15. PK parameters - Renal clearance (CLr) of unchanged edaravone after oral and intravenous administration [Day 1 to 2]

16. PK parameters - Bioavailability (F) of unchanged edaravone [Day 1 to 2]

17. PK parameters - Area under the plasma concentration versus time curve from time zero up to the last quantifiable concentration time-point (AUC0-t) of sulfate and glucuronide conjugates after oral and intravenous administration [Day 1 to 2]

18. PK parameters - Area under the plasma concentration versus time curve from time zero up to infinity with extrapolation of the terminal phase (AUC0-inf) of sulfate and glucuronide conjugates after oral and intravenous administration [Day 1 to 2]

19. PK parameters - Maximum plasma concentration (Cmax) of sulfate and glucuronide conjugates after oral and intravenous administration [Day 1 to 2]

20. Number of Participants with Adverse events and adverse drug reactions [Day 1 to 11]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy adult male or female volunteers

• Japanese

• 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

• Female subjects who do not agree to use an effective method of contraception from screening or 2 weeks before the start of investigational product administration, whichever comes earlier, to 14 days after the completion (or discontinuation) of investigational product administration. Male subjects who do not agree to use an effective method of contraception from the start of investigational product administration to 14 days after the completion (or discontinuation) of investigational product administration

• Subjects who have previously received edaravone

• Subjects who have participated in another clinical study and received an investigational product within 12 weeks before providing informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational site	Tokyo		Japan

Sponsors and Collaborators

• Mitsubishi Tanabe Pharma Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mitsubishi Tanabe Pharma Corporation
• ClinicalTrials.gov Identifier: NCT04493281
• Other Study ID Numbers: MT-1186-J03
• First Posted: Jul 30, 2020
• Last Update Posted: Aug 5, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Edaravone

Study Results

No Results Posted as of Aug 5, 2020