Clincosm LogoSign in Get a demo

Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy

Sponsor
Mitsubishi Tanabe Pharma Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT04254913
Collaborator
(none)
6
Enrollment
1
Location
1
Arm
2.9
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Amyotrophic Lateral Sclerosis Patients with gastrostomy

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
6 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy
Actual Study Start Date :
Jan 24, 2020
Actual Primary Completion Date :
Apr 16, 2020
Actual Study Completion Date :
Apr 22, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: MT-1186

Patients receive the edaravone oral suspension.

Drug: MT-1186
Suspension
Other Names:
  • Edaravone

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Plasma concentrations of edaravone [Day 1 to 2]

    2. Urine concentrations of edaravone [Day 1]

    3. Area under the concentration versus time curve (AUC) of edaravone [Day 1 to 2]

    4. Maximum plasma concentration (Cmax) of edaravone [Day 1 to 2]

    5. Time to reach maximum plasma concentration (tmax) of edaravone [Day 1 to 2]

    6. Terminal elimination half-life (t1/2) of edaravone [Day 1 to 2]

    7. Apparent terminal elimination rate constant (Kel) of edaravone [Day 1 to 2]

    8. Mean residence time (MRT) of edaravone [Day 1 to 2]

    9. Apparent total clearance (CL/F) of edaravone [Day 1 to 2]

    10. Apparent distribution volume at elimination phase (Vz/F) of edaravone [Day 1 to 2]

    11. Apparent distribution volume at steady state (Vss/F) of edaravone [Day 1 to 2]

    12. Cumulative amount of drug excreted in urine (Ae) of edaravone [Day 1 to 2]

    13. Cumulative percentage of drug excreted in urine (Ae%) of edaravone [Day 1 to 2]

    14. Apparent renal clearance (CLr/F) of edaravone [Day 1 to 2]

    Secondary Outcome Measures

    1. Number of Participants with Adverse events and adverse drug reactions [The provision of informed consent to Day 8]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    The key criteria are listed below.

    • Patients aged between 20 and 80 years at the time of informed consent

    • Japanese patients

    • Among patients with ALS, those "Clinically definite ALS," "Clinically probable ALS" or "Clinically probable-laboratory-supported ALS" according to El Escorial Revised Airlie House criteria

    • ALS Patients with gastrostomy

    • Patients who can consent to contraception

    • Patients who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study

    Exclusion Criteria:

    The key criteria are listed below.

    • Patients in whom the possibility could not be ruled out that the current symptoms were symptoms of a disease requiring differential diagnosis, such as cervical spondylosis and multifocal motor neuropathy

    • Patients undergoing treatment for malignancy.

    • Patients who have presence of clinically significant liver, heart, or renal disease requiring hospitalization (except ALS) and infections requiring antibiotics. Patients who have a problem in general condition and are judged ineligible by the Investigator

    • Body mass index (BMI) of <15.0 or >30.0, or a body weight of <40 kg

    • Patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Investigational site Chiba 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:
    NCT04254913
    Other Study ID Numbers:
    • MT-1186-J05
    First Posted:
    Feb 5, 2020
    Last Update Posted:
    Oct 1, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Motor Neuron Disease
    Amyotrophic Lateral Sclerosis
    Edaravone

    Study Results

    No Results Posted as of Oct 1, 2020