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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: TRK-700; Drug: Midazolam; Drug: Digoxin

• Registration Number: NCT03043248
• Lead Sponsor: Toray Industries, Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-02
• Study First Submitted QC: 2017-02-02
• Study First Posted: 2017-02-03
• Study Start: 2017-02-06
• Primary Completion: 2017-05-13
• Study Completion: 2017-05-21
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort B	Midazolam	TRK-700 + Midazolam
Cohort A	TRK-700	TRK-700 + Digoxin
Cohort A	Digoxin	TRK-700 + Digoxin
Cohort B	TRK-700	TRK-700 + Midazolam

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Tokyo; 🇯🇵 Tokyo, Japan