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

Primary Purpose

Japanese Patients With ALS

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
MT-1186
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Japanese Patients With ALS

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MT-1186

Arm Description

Patients receive the edaravone oral suspension.

Outcomes

Primary Outcome Measures

Plasma concentrations of edaravone
Urine concentrations of edaravone
Area under the concentration versus time curve (AUC) of edaravone
Maximum plasma concentration (Cmax) of edaravone
Time to reach maximum plasma concentration (tmax) of edaravone
Terminal elimination half-life (t1/2) of edaravone
Apparent terminal elimination rate constant (Kel) of edaravone
Mean residence time (MRT) of edaravone
Apparent total clearance (CL/F) of edaravone
Apparent distribution volume at elimination phase (Vz/F) of edaravone
Apparent distribution volume at steady state (Vss/F) of edaravone
Cumulative amount of drug excreted in urine (Ae) of edaravone
Cumulative percentage of drug excreted in urine (Ae%) of edaravone
Apparent renal clearance (CLr/F) of edaravone

Secondary Outcome Measures

Number of Participants with Adverse events and adverse drug reactions

Full Information

First Posted
January 23, 2020
Last Updated
September 29, 2020
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT04254913
Brief Title
Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy
Official Title
Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 24, 2020 (Actual)
Primary Completion Date
April 16, 2020 (Actual)
Study Completion Date
April 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Japanese Patients With ALS

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MT-1186
Arm Type
Experimental
Arm Description
Patients receive the edaravone oral suspension.
Intervention Type
Drug
Intervention Name(s)
MT-1186
Other Intervention Name(s)
Edaravone
Intervention Description
Suspension
Primary Outcome Measure Information:
Title
Plasma concentrations of edaravone
Time Frame
Day 1 to 2
Title
Urine concentrations of edaravone
Time Frame
Day 1
Title
Area under the concentration versus time curve (AUC) of edaravone
Time Frame
Day 1 to 2
Title
Maximum plasma concentration (Cmax) of edaravone
Time Frame
Day 1 to 2
Title
Time to reach maximum plasma concentration (tmax) of edaravone
Time Frame
Day 1 to 2
Title
Terminal elimination half-life (t1/2) of edaravone
Time Frame
Day 1 to 2
Title
Apparent terminal elimination rate constant (Kel) of edaravone
Time Frame
Day 1 to 2
Title
Mean residence time (MRT) of edaravone
Time Frame
Day 1 to 2
Title
Apparent total clearance (CL/F) of edaravone
Time Frame
Day 1 to 2
Title
Apparent distribution volume at elimination phase (Vz/F) of edaravone
Time Frame
Day 1 to 2
Title
Apparent distribution volume at steady state (Vss/F) of edaravone
Time Frame
Day 1 to 2
Title
Cumulative amount of drug excreted in urine (Ae) of edaravone
Time Frame
Day 1 to 2
Title
Cumulative percentage of drug excreted in urine (Ae%) of edaravone
Time Frame
Day 1 to 2
Title
Apparent renal clearance (CLr/F) of edaravone
Time Frame
Day 1 to 2
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse events and adverse drug reactions
Time Frame
The provision of informed consent to Day 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
General Manager
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Investigational site
City
Chiba
Country
Japan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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