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Study of Oral Edaravone in Healthy Adult Males

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT04481750
Collaborator
(none)
74
Enrollment
1
Location
10
Arms
4.5
Actual Duration (Months)
16.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
74 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Single Blind
Primary Purpose:
Other
Official Title:
Phase I Study of Oral Edaravone in Healthy Adult Males (Single- and Multiple-dose Study)
Actual Study Start Date :
Mar 20, 2018
Actual Primary Completion Date :
Aug 3, 2018
Actual Study Completion Date :
Aug 3, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: A single dose MT-1186 (Part 1, Cohort S1)

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

Drug: MT-1186
Solution or suspension
Other Names:
  • Edaravone

    • Drug: MT-1186-matching placebo
    Solution or suspension
    Experimental: A single dose MT-1186 (Part 1, Cohort S2)

    Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

    Drug: MT-1186
    Solution or suspension
    Other Names:
  • Edaravone

    • Drug: MT-1186-matching placebo
    Solution or suspension
    Experimental: A single dose MT-1186 (Part 1, Cohort S3-1)

    Healthy Japanese male subjects receive doses of MT-1186 or matching placebo.

    Drug: MT-1186
    Solution or suspension
    Other Names:
  • Edaravone

    • Drug: MT-1186-matching placebo
    Solution or suspension
    Experimental: A single dose MT-1186 (Part 1, Cohort S3-2)

    Healthy Japanese male subjects receive doses of MT-1186 or matching placebo.

    Drug: MT-1186
    Solution or suspension
    Other Names:
  • Edaravone

    • Drug: MT-1186-matching placebo
    Solution or suspension
    Experimental: A single dose MT-1186 (Part 1, Cohort S4)

    Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

    Drug: MT-1186
    Solution or suspension
    Other Names:
  • Edaravone

    • Drug: MT-1186-matching placebo
    Solution or suspension
    Experimental: A single dose MT-1186 (Part 1, Cohort S5)

    Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

    Drug: MT-1186
    Solution or suspension
    Other Names:
  • Edaravone

    • Drug: MT-1186-matching placebo
    Solution or suspension
    Experimental: A single dose MT-1186 (Part 1, Cohort S6)

    Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

    Drug: MT-1186
    Solution or suspension
    Other Names:
  • Edaravone

    • Drug: MT-1186-matching placebo
    Solution or suspension
    Experimental: A single dose MT-1186 (Part 1, Cohort S7)

    Healthy Caucasian male subjects receive a single dose of MT-1186 or matching placebo.

    Drug: MT-1186
    Solution or suspension
    Other Names:
  • Edaravone

    • Drug: MT-1186-matching placebo
    Solution or suspension
    Experimental: Multiple doses MT-1186 (Part 2, Cohort M1)

    Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo.

    Drug: MT-1186
    Solution or suspension
    Other Names:
  • Edaravone

    • Drug: MT-1186-matching placebo
    Solution or suspension
    Experimental: Multiple doses MT-1186 (Part 2, Cohort M2)

    Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo

    Drug: MT-1186
    Solution or suspension
    Other Names:
  • Edaravone

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

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Adverse events and adverse drug reactions [Day 1 to 8 in part 1, day1 to 12 in part 2]

    2. Plasma concentrations [Day 1 to 3 in part 1, day 1 to 7 in part 2]

      Plasma concentrations of unchanged edaravone, sulfate, and glucuronide for PK analysis

    3. PK parameters - Area under the concentration versus time curve (AUC) of unchanged edaravone, sulfate, and glucuronide [Day 1 to 3 in part 1, day 1 to 7 in part 2]

      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)

    4. 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]

    5. PK parameters - Minimum plasma concentration (Ctrough) of unchanged edaravone, sulfate, and glucuronide [Day 1 to 7 in part 2]

    6. 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]

    7. 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]

    8. PK parameters - Lambda-z of unchanged edaravone, sulfate, and glucuronide [Day 1 to 3 in part 1, day 1 to 7 in part 2]

    9. PK parameters - Mean residence time (MRT) of unchanged edaravone [Day 1 to 3 in part 1, day 1 to 7 in part 2]

    10. PK parameters - Apparent total clearance (CL/F) of unchanged edaravone [Day 1 to 3 in part 1, day 1 to 7 in part 2]

    11. 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]

    12. 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 Outcome Measures

    1. Heart rate [Day 1 to 3 in cohort 4, 5 and 6 in part 1]

    2. PR interval [Day 1 to 3 in cohort 4, 5 and 6 in part 1]

    3. QT interval [Day 1 to 3 in cohort 4, 5 and 6 in part 1]

    4. QTcF [Day 1 to 3 in cohort 4, 5 and 6 in part 1]

    5. QRS interval [Day 1 to 3 in cohort 4, 5 and 6 in part 1]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational Site Osaka Japan

    Sponsors and Collaborators

    • Mitsubishi Tanabe Pharma Corporation

    Investigators

    • Study Director: General Manager, Mitsubishi Tanabe Pharma Corporation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mitsubishi Tanabe Pharma Corporation
    ClinicalTrials.gov Identifier:
    NCT04481750
    Other Study ID Numbers:
    • MT-1186-J01
    First Posted:
    Jul 22, 2020
    Last Update Posted:
    Jul 29, 2020
    Last Verified:
    Jul 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 Jul 29, 2020