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

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03043248

Enrollment

Registered

2017-02-03

Start date

2017-02-06

Completion date

2017-05-21

Last updated

2017-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

TRK-700, PK, Digoxin, Midazolam, Drug-Drug interaction, P-glycoprotein, CYP3A4, MDR1, pharmacokinetics, multidrug resistance 1

Brief 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.

Interventions

DRUGTRK-700

repeated oral administration

DRUGDigoxin

single oral administration with/without TRK-700

DRUGMidazolam

single oral administration with/without TRK-700

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

20 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

* Japanese healthy adult males. * Subjects with a BMI of at least 18.0 and less than 30.0 at the screening examination and the examination at admission.

Exclusion criteria

* Subjects with significant concomitant or historical disease of the metabolism, liver, kidneys, blood, lungs, heart, digestive organs, urinary organs, or nerves, or psychiatric diseases, accompanied by clinical symptoms or with other clinically significant disease, who are unsuitable for participation in this study, in the opinion of the investigators. * Subjects who are found by the investigators to have significant clinical abnormality at the screening examination, the examination at admission, or the examination at the day of first administration of Digoxin or Midazolam.

Design outcomes

Primary

Measure	Time frame
Area under the plasma drug concentration - time curve from administration to the last available concentration measurement of Digoxin and Midazolam(AUClast)	Cohort A: up to 72 hours, Cohort B: up to 48 hours

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026