Conditions: Healthy Adult Subjects
Allocation: NON_RANDOMIZED | Intervention model: SEQUENTIAL
Enrollment: 84
Healthy volunteers: yes

Brief 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

Detailed description:

Arms:
arm 1: Group 1 of Cohort 1:

A single-sequence study in which healthy male subjects receive a single dose of rosuvastatin on Day 1 followed by a single dose of sildenafil on Day 4. MT-1186 will be administered from Day 6 to 13 with co-administration of rosuvastatin and sildenafil on Day 9 and 12, respectively. arm 2: Group 2 of Cohort 1:

A single-sequence study in which healthy male subjects receive a single dose of furosemide on Day 1. MT-1186 will be administered from Day 3 to 7 with co-administration of furosemide on Day 6. arm 3: Cohort 2:

A three-way crossover study in which Japanese healthy male subjects receive a single dose of MT-1186 under several dosing condition on Day 1, 4, and 7 according to their treatment sequence with 3-day wash out between doses. Caucasian healthy male subjects receive a single dose of MT-1186 at the same period with Japanese subjects under the corresponding condition on Day 1, 4, or 7 according to their treatment schedule.

Interventions: intervention 1: MT-1186 intervention 2: Rosuvastatin intervention 3: Sildenafil intervention 4: Furosemide
Intervention descriptions: intervention 1: Suspension intervention 2: Tablets intervention 3: Tablets intervention 4: Tablets

Protocol document:
Prot_000.pdf: 





















































































































































































































SAP_001.pdf: