Clinical trial NCT04254913: Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy
Official title: Clinical Pharmacology Study of Oral Edaravone in Amyotrophic Lateral Sclerosis Patients With Gastrostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Japanese Patients With ALS
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2020-02-05
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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 \<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

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve From Time Zero up to the Last Quantifiable Concentration Time-point (AUC0-t) of Unchanged Edaravone
timeFrame: 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.
measure: Maximum Plasma Concentration (Cmax) of Unchanged Edaravone
timeFrame: 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.
measure: Time to Reach Maximum Plasma Concentration (Tmax) of Unchanged Edaravone
timeFrame: 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.
measure: Terminal Elimination Half-life (t1/2) of Unchanged Edaravone
timeFrame: 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.
measure: Apparent Terminal Elimination Rate Constant (Kel) of Unchanged Edaravone
timeFrame: 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.
measure: Mean Residence Time (MRT) of Unchanged Edaravone
timeFrame: 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.
measure: Apparent Total Clearance (CL/F) of Unchanged Edaravone
timeFrame: 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.
measure: Apparent Distribution Volume at Elimination Phase (Vz/F) of Unchanged Edaravone
timeFrame: 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.
measure: Apparent Distribution Volume at Steady State (Vss/F) of Unchanged Edaravone
timeFrame: 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
measure: Cumulative Amount of Drug Excreted in Urine (Ae) of Edaravone
timeFrame: Urine samples are collected: 0 to 8 hours after oral administration
measure: Cumulative Percentage of Drug Excreted in Urine (Ae) of Edaravone
timeFrame: Urine samples are collected: 0 to 8 hours after oral administration
measure: Renal Clearance (CLr) of Edaravone
timeFrame: Urine samples are collected: 0 to 8 hours after oral administration
Secondary outcomes:
measure: Number of Participants With Adverse Events and Adverse Drug Reactions
timeFrame: The provision of informed consent to Day 8
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: Investigational site
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References: