Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy
- Registration Number
- NCT04254913
- Lead Sponsor
- Mitsubishi Tanabe Pharma Corporation
- Brief Summary
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Amyotrophic Lateral Sclerosis Patients with gastrostomy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description MT-1186 MT-1186 Patients receive the edaravone oral suspension.
- Primary Outcome Measures
Name Time Method 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. 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 Percentage of Drug Excreted in Urine (Ae) of Edaravone Urine samples are collected: 0 to 8 hours after oral administration This information will not be disclosed because it may identify the patient (N=1)
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. 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. Cumulative Amount of Drug Excreted in Urine (Ae) of Edaravone Urine samples are collected: 0 to 8 hours after oral administration This information will not be disclosed because it may identify the patient (N=1).
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 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. Renal Clearance (CLr) of Edaravone Urine samples are collected: 0 to 8 hours after oral administration This information will not be disclosed because it may identify the patient (N=1).
- Secondary Outcome Measures
Name Time Method Number of Participants With Adverse Events and Adverse Drug Reactions The provision of informed consent to Day 8
Trial Locations
- Locations (1)
Investigational site
🇯🇵Chiba, Japan