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

Toray Industries

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Midazolam; Drug: Digoxin; Drug: TRK-700

Study type: Interventional

Funder types: Industry

Identifiers

NCT03043248

700P1C03

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

48 participants in 2 patient groups

Cohort A

Experimental group

Description:

TRK-700 + Digoxin

Treatment:

Drug: TRK-700

Drug: Digoxin

Cohort B

Experimental group

Description:

TRK-700 + Midazolam

Treatment:

Drug: Midazolam

Drug: TRK-700