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Clinical Pharmacology Study of Oral Edaravone in Healthy Adult Males (Drug Interaction Study and Preliminary Regimen-Finding Study)

NCT04481789 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2026-05-22

Study results available
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Summary

* Cohort 1: To evaluate the drug interactions, safety, and tolerability of oral edaravone when coadministered with rosuvastatin, sildenafil or furosemide in healthy adult males
* Cohort 2: To evaluate the pharmacokinetics, safety, and tolerability of oral edaravone in healthy Japanese and Caucasian adult males

Conditions

  • Healthy Adult Subjects

Interventions

DRUG

MT-1186

Suspension

DRUG

Rosuvastatin

Tablets

DRUG

Sildenafil

Tablets

DRUG

Furosemide

Tablets

Sponsors & Collaborators

  • Tanabe Pharma Corporation

    lead INDUSTRY

Principal Investigators

  • General Manager · Tanabe Pharma Corporation

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-17
Primary Completion
2018-12-20
Completion
2019-01-08

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04481789 on ClinicalTrials.gov