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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03043248
• Other study ID #: 700P1C03
• Status: Completed
• Phase: Phase 1
• First received: February 2, 2017
• Last updated: October 24, 2017
• Start date: February 6, 2017
• Est. completion date: May 21, 2017

Study information

• Verified date: October 2017
• Source: Toray Industries, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 21, 2017
• Est. primary completion date: May 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• TRK-700
repeated oral administration
• Digoxin
single oral administration with/without TRK-700
• Midazolam
single oral administration with/without TRK-700

Locations

Country	Name	City	State
Japan	Tokyo	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Toray Industries, Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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