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Drug-Drug Interaction Study Between TAK-272 and Itraconazole, Digoxin or Midazolam

NCT02370615 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2016-05-23

Study results available
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Summary

The purpose of this study is to evaluate the effect of repeated-dose administration of itraconazole on the pharmacokinetics of TAK-272, as well as the effect of repeated-dose administration of TAK-272 on the pharmacokinetics of digoxin or midazolam in healthy Japanese adult males.

Conditions

  • Japanese Healthy Adult Males

Interventions

DRUG

TAK-272

TAK-272 tablet.

DRUG

Digoxin

Digoxin tablet.

DRUG

Itraconazole

Itraconazole oral solution

DRUG

Midazolam

Midazolam syrup.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02370615 on ClinicalTrials.gov