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

NCT03043248 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2017-10-25

No results posted yet for this study

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

DRUG

TRK-700

repeated oral administration

DRUG

Digoxin

single oral administration with/without TRK-700

DRUG

Midazolam

single oral administration with/without TRK-700

Sponsors & Collaborators

  • Toray Industries, Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03043248 on ClinicalTrials.gov