Clinical Pharmacology Study of Oral Edaravone in ALS Patients with PEG

Phase 1

Completed

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: JPRN-jRCT2080225036
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

Brief Summary

In 6 subjects with ALS, edaravone was well absorbed after administration of edaravone oral suspension via a PEG tube with tmax of 0.25-0.50 hours. The mean Cmax and AUC0-inf of unchanged edaravone after oral administration of 105 mg edaravone were 2163 ng/mL and 2310 ng*h/mL, respectively. The edaravone was mainly eliminated into urine as glucuronide conjugate and subdominantly as sulfate conjugate after oral administration via a PEG tube. There were no safety concerns in the results of this study.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-23
• Study Completion: 2020-04-22
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: completed
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

The key criteria are listed below.
1. Patients aged between 20 and 80 years at the time of informed consent
2. Japanese patients
3. 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
4. ALS Patients with gastrostomy
5. Patients who can consent to contraception
6. 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.
1. 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
2. Patients undergoing treatment for malignancy.
3. 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
4. Body mass index (BMI) of <15.0 or >30.0, or a body weight of <40 kg
5. Patients judged by the investigator (or subinvestigator) to be unsuitable for the study for any other reason

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetic<br>1. Drug concentration in plasma and urine<br>2. PK parameters<br>AUC, Cmax, tmax, t1/2, Kel, MRT, CL/F, Vz/F, Vss/F, Ae, Ae%, CLr

Secondary Outcome Measures

Name	Time	Method
Safety<br>Adverse events