Clinical trial
Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy
Name
MT-1186-J05
Description
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Amyotrophic Lateral Sclerosis Patients with gastrostomy
Trial arms
Trial start
2020-01-24
Estimated PCD
2020-04-16
Trial end
2020-04-22
Status
Completed
Phase
Early phase I
Treatment
MT-1186
Suspension
Arms:
MT-1186
Other names:
Edaravone
Size
6
Primary endpoint
Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone
Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.
Maximum Plasma Concentration (Cmax) of Unchanged Edaravone
Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.
Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone
Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.
Terminal Elimination Half-life (t1/2) of Unchanged Edaravone
Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.
Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone
Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.
Mean Residence Time (MRT) of Unchanged Edaravone
Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.
Apparent Total Clearance (CL/F) of Unchanged Edaravone
Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.
Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone
Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration.
Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone
Plasma samples are collected: Day 1 at pre-dose, 0.25, 0.5, 1, 2, 4 and 8 hours; Day 2 at 24 hours after administration
Cumulative Amount of Drug Excreted in Urine (Ae) of Edaravone
Urine samples are collected: 0 to 8 hours after oral administration
Cumulative Percentage of Drug Excreted in Urine (Ae) of Edaravone
Urine samples are collected: 0 to 8 hours after oral administration
Renal Clearance (CLr) of Edaravone
Urine samples are collected: 0 to 8 hours after oral administration
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'OTHER', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}
Updated at
2024-01-24
1 organization
1 product
1 indication
Organization
Mitsubishi Tanabe PharmaProduct
MT-1186Indication
Amyotrophic Lateral Sclerosis