Study of Oral Edaravone in Healthy Adult Males

Tanabe Pharma Corporation

Status and phase: Completed; Phase 1

Conditions: Healthy Adult Subjects

Treatments: Drug: MT-1186-matching placebo; Drug: MT-1186

Study type: Interventional

Funder types: Industry

Identifiers

NCT04481750

MT-1186-J01

Details and patient eligibility

About

To evaluate the pharmacokinetics safety, and tolerability of single and multiple doses of edaravone solution and suspension in healthy adult males

Enrollment: 74 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Additional screening criteria check may apply for qualification:

• Healthy adult male volunteers
• Japanese or Caucasian
• Subjects aged between 20 and 45 years at the time of informed consent
• Subjects who have thoroughly understood the contents of the study and voluntarily provided written informed consent to participate in the study

Exclusion criteria

Additional screening criteria check may apply for qualification:

• Subjects with a current or previous history of cardiac, hepatic, renal, gastrointestinal, respiratory, psychiatric/nervous, hematopoietic, or endocrine diseases, and those whom the investigator (or subinvestigator) deems unsuitable for the study
• Body mass index (BMI) of <18.0 or >30.0, or body weight of <50 kg (BMI formula: body weight [kg]/height [m]2, rounded to one decimal place)
• Subjects who have undergone any surgery known to affect the gastrointestinal absorption of drugs
• Subjects who do not agree to use an effective method of contraception from initiation of study drug administration to 14 days after completion (discontinuation) of study drug administration
• Subjects who have previously received edaravone
• Subjects who have participated in another clinical study and received a study drug within 12 weeks before providing informed consent

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 10 patient groups

A single dose MT-1186 (Part 1, Cohort S1)

Experimental group

Description:

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

Treatment:

Drug: MT-1186

Drug: MT-1186-matching placebo

A single dose MT-1186 (Part 1, Cohort S2)

Experimental group

Description:

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

Treatment:

Drug: MT-1186

Drug: MT-1186-matching placebo

A single dose MT-1186 (Part 1, Cohort S3-1)

Experimental group

Description:

Healthy Japanese male subjects receive doses of MT-1186 or matching placebo.

Treatment:

Drug: MT-1186

Drug: MT-1186-matching placebo

A single dose MT-1186 (Part 1, Cohort S3-2)

Experimental group

Description:

Healthy Japanese male subjects receive doses of MT-1186 or matching placebo.

Treatment:

Drug: MT-1186

Drug: MT-1186-matching placebo

A single dose MT-1186 (Part 1, Cohort S4)

Experimental group

Description:

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

Treatment:

Drug: MT-1186

Drug: MT-1186-matching placebo

A single dose MT-1186 (Part 1, Cohort S5)

Experimental group

Description:

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

Treatment:

Drug: MT-1186

Drug: MT-1186-matching placebo

A single dose MT-1186 (Part 1, Cohort S6)

Experimental group

Description:

Healthy Japanese male subjects receive a single dose of MT-1186 or matching placebo.

Treatment:

Drug: MT-1186

Drug: MT-1186-matching placebo

A single dose MT-1186 (Part 1, Cohort S7)

Experimental group

Description:

Healthy Caucasian male subjects receive a single dose of MT-1186 or matching placebo.

Treatment:

Drug: MT-1186

Drug: MT-1186-matching placebo

Multiple doses MT-1186 (Part 2, Cohort M1)

Experimental group

Description:

Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo.

Treatment:

Drug: MT-1186

Drug: MT-1186-matching placebo

Multiple doses MT-1186 (Part 2, Cohort M2)

Experimental group

Description:

Healthy Japanese male subjects receive multiple doses of MT-1186 or matching placebo

Treatment:

Drug: MT-1186

Drug: MT-1186-matching placebo