Phase 1
N=9
Clinical Pharmacology Study of Oral Edaravone in Patients With Amyotrophic Lateral Sclerosis
Japanese Patients With ALS
Bottom Line
View on ClinicalTrials.gov: NCT04176224 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Jan 2024
Primary outcome: Primary: Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone — 1719 ng·h/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- MT-1186 (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone |
1719 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Unchanged Edaravone |
1903 | — |
| PRIMARY Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone |
0.25 | — |
| PRIMARY Terminal Elimination Half-life (t1/2) of Unchanged Edaravone |
6.11 | — |
| PRIMARY Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone |
0.118 | — |
| PRIMARY Mean Residence Time (MRT) of Unchanged Edaravone |
2.14 | — |
| PRIMARY Apparent Total Clearance (CL/F) of Unchanged Edaravone |
72.5 | — |
| PRIMARY Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone |
603 | — |
| PRIMARY Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone |
155.7 | — |
| PRIMARY Cumulative Amount of Drug Excreted in Urine From Time Zero up to 24 Hours (Ae0-24) of Unchanged Edaravone |
0.534 | — |
| PRIMARY Cumulative Percentage of Drug Excreted in Urine From Time Zero up to 24 Hours (Ae0-24) of Unchanged Edaravone |
0.508 | — |
| PRIMARY Renal Clearance (CLr) of Unchanged Edaravone |
0.374 | — |
| SECONDARY Number of Participants With Adverse Events and Adverse Drug Reactions |
1; 0 | — |
Summary
To evaluate the pharmacokinetics of single doses of edaravone oral suspension in Patients with Amyotrophic Lateral Sclerosis
Eligibility Criteria
Inclusion Criteria
The key criteria are listed below.
- Patients aged between 20 and 75 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
- 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 30.0, or a body weight of <50 kg
- Patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason
Data sourced from ClinicalTrials.gov (NCT04176224). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.