NCT03043248

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

TRK-700 Drug-Drug Interaction Study With Digoxin and Midazolam in Healthy Adults

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Toray Industries, Inc · Industry
• Sex: Male
• Age: 20 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	TRK-700	repeated oral administration
DRUG	Digoxin	single oral administration with/without TRK-700
DRUG	Midazolam	single oral administration with/without TRK-700

Timeline

• Start date: 2017-02-06
• Primary completion: 2017-05-13
• Completion: 2017-05-21
• First posted: 2017-02-03
• Last updated: 2017-10-25

Locations

1 site across 1 country: Japan