Japanese Healthy Adult Males Clinical Trial
Official title:
An Open-label, Phase 1, Drug-Drug Interaction Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of TAK-272 and the Effect of TAK-272 on the Pharmacokinetics of Digoxin and Midazolam in the Healthy Adult Subjects
The purpose of this study is to investigate the effect of repeated-dose administration of itraconazole on the pharmacokinetics of TAK-272 and the effect of repeated-dose administration of TAK-272 on the pharmacokinetics of digoxin and midazolam in healthy Japanese adult males.
In cohort 1, the pharmacokinetics of TAK-272 will be compared between subjects receiving TAK-272 alone and those receiving TAK-272 in combination with itraconazole to investigate the effect of repeated-dose administration of itraconazole on the pharmacokinetics of TAK-272. In cohort 2, the pharmacokinetics of digoxin or midazolam will be compared between subjects receiving digoxin and midazolam alone and those receiving either of the drugs in combination with TAK-272 to investigate the effect of repeated-dose administration of TAK-272 on the pharmacokinetics of digoxin and midazolam. ;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02401464 -
A Phase I Bioequivalence Study of TAK-536 Pediatric Formulation
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Phase 1 |