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Completed

NCT Number: NCT03043248

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

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.

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Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Tokyo

Tokyo, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TRK-700

Drug

repeated oral administration

Digoxin

Drug

single oral administration with/without TRK-700

midazolam

Drug

single oral administration with/without TRK-700

Primary outcomes

  1. Area under the plasma drug concentration - time curve from administration to the last available concentration measurement of Digoxin and Midazolam(AUClast)

    Time frame: Cohort A: up to 72 hours, Cohort B: up to 48 hours

Sponsors and collaborators

Lead sponsor

Toray Industries, Inc

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 3, 2017
Registry last updated
Oct 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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