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

NCT ID: NCT03043248

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-06

Study Completion Date

2017-05-21

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Keywords

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Cohort A

TRK-700 + Digoxin

Group Type EXPERIMENTAL

TRK-700

Intervention Type DRUG

repeated oral administration

Digoxin

Intervention Type DRUG

single oral administration with/without TRK-700

Cohort B

TRK-700 + Midazolam

Group Type EXPERIMENTAL

TRK-700

Intervention Type DRUG

repeated oral administration

Midazolam

Intervention Type DRUG

single oral administration with/without TRK-700

Interventions

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TRK-700

repeated oral administration

Intervention Type DRUG

Digoxin

single oral administration with/without TRK-700

Intervention Type DRUG

Midazolam

single oral administration with/without TRK-700

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Toray Industries, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tokyo

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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700P1C03

Identifier Type: -

Identifier Source: org_study_id