Conditions: Japanese Healthy Adult Males
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 34
Healthy volunteers: yes

Brief summary:
The purpose of this study is to evaluate the effect of repeated-dose administration of itraconazole on the pharmacokinetics of TAK-272, as well as the effect of repeated-dose administration of TAK-272 on the pharmacokinetics of digoxin or midazolam in healthy Japanese adult males.

Detailed description:
In Cohort 1, the effect of repeated-dose administration of itraconazole on the pharmacokinetics of TAK-272 was evaluated by comparing between participants receiving TAK-272 alone and those receiving TAK-272 in combination with itraconazole. In Cohort 2, the effect of repeated-dose administration of TAK-272 on the pharmacokinetics of digoxin or midazolam was evaluated by comparing between participants receiving digoxin or midazolam alone and those receiving either of the drugs in combination with TAK-272.

Arms:
arm 1: TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12. arm 2: Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.

Interventions: intervention 1: TAK-272 intervention 2: Digoxin intervention 3: Itraconazole intervention 4: Midazolam
Intervention descriptions: intervention 1: TAK-272 tablet. intervention 2: Digoxin tablet. intervention 3: Itraconazole oral solution intervention 4: Midazolam syrup.

Protocol document: