Phase 1 N=6 Other

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

Japanese Patients With ALS

Bottom Line

View on ClinicalTrials.gov: NCT04254913 ↗

Enrolled (actual)

Serious AEs

33.3%

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 — 2300 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: Apr 2020

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	2300	—
PRIMARY Maximum Plasma Concentration (Cmax) of Unchanged Edaravone	2163	—
PRIMARY Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone	0.29	—
PRIMARY Terminal Elimination Half-life (t1/2) of Unchanged Edaravone	4.47	—
PRIMARY Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone	0.1561	—
PRIMARY Mean Residence Time (MRT) of Unchanged Edaravone	1.89	—
PRIMARY Apparent Total Clearance (CL/F) of Unchanged Edaravone	54.4	—
PRIMARY Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone	365	—
PRIMARY Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone	101	—
PRIMARY Cumulative Amount of Drug Excreted in Urine (Ae) of Edaravone	NA	—
PRIMARY Cumulative Percentage of Drug Excreted in Urine (Ae) of Edaravone	NA	—
PRIMARY Renal Clearance (CLr) of Edaravone	NA	—
SECONDARY Number of Participants With Adverse Events and Adverse Drug Reactions	3; 0	—

Summary

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

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04254913). 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.