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

NCT03043248 | Completed Phase 1

• 1 other identifier: 700P1C03
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

TRK-700; PK; Digoxin; Midazolam; Drug-Drug interaction; P-glycoprotein; CYP3A4; MDR1; pharmacokinetics; multidrug resistance 1

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cohort A

EXPERIMENTAL

TRK-700 + Digoxin

Drug: TRK-700; Drug: Digoxin

Cohort B

EXPERIMENTAL

TRK-700 + Midazolam

Drug: TRK-700; Drug: Midazolam

Interventions

TRK-700 DRUG

repeated oral administration

Cohort A; Cohort B

Digoxin DRUG

single oral administration with/without TRK-700

Cohort A

Midazolam DRUG

single oral administration with/without TRK-700

Cohort B

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Toray Industries, Inc: lead

Study Sites (1)

Tokyo

Tokyo, Japan

Location

MeSH Terms

Interventions

Digoxin; Midazolam

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2017
• First Posted: February 3, 2017
• Study Start: February 6, 2017
• Primary Completion: May 13, 2017
• Study Completion: May 21, 2017
• Last Updated: October 25, 2017

Record last verified: 2017-10

Locations

JP (1)