drugset / Trial / NCT03043248

TRK-700 Drug-Drug Interaction Study With Digoxin and Midazolam

NCT03043248 ↗

Phase 1 Completed 48 enrolled Toray Industries, Inc
Non-randomizedSingle-groupOpen-labelOther

Summary

This study comprises 2 cohorts, and in each cohort, the study will be conducted as an open-label add-on study. The purpose of the study is to investigate the pharmacokinetics of each substrate in concomitant administration of a single dose of the P-glycoprotein substrate digoxin (Cohort A) or the CYP3A4 substrate midazolam (Cohort B) during repeated administration of TRK-700 in healthy adult males.

Timeline

Start
2017-02-06
Primary completion
2017-05-13
Completion
2017-05-21

Drugs

EvaluationDrugModalityDoseRoute
Subject Digoxin Other / unclassified — Oral
Subject Midazolam Small molecule — Oral
Subject TRK-700 Unknown — Oral

Indications

No indication recorded.