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

Sponsor

Toray Industries, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT03043248

Collaborator

(none)

Enrollment

Location

Arms

3.4

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

or the CYP3A4 substrate midazolam (Cohort B) during repeated administration of TRK-700 in healthy adult males.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Drug: TRK-700 Drug: Digoxin Drug: Midazolam	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 6, 2017

Actual Primary Completion Date :

May 13, 2017

Actual Study Completion Date :

May 21, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A TRK-700 + Digoxin	Drug: TRK-700 repeated oral administration Drug: Digoxin single oral administration with/without TRK-700
Experimental: Cohort B TRK-700 + Midazolam	Drug: TRK-700 repeated oral administration Drug: Midazolam single oral administration with/without TRK-700

Arm

Intervention/Treatment

Experimental: Cohort A

TRK-700 + Digoxin

Drug: TRK-700

repeated oral administration

Drug: Digoxin

single oral administration with/without TRK-700

Experimental: Cohort B

TRK-700 + Midazolam

Drug: TRK-700

repeated oral administration

Drug: Midazolam

single oral administration with/without TRK-700

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts 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.