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A Study to Evaluate the Effect of the Potent CYP3A4 Inhibitor Itraconazole on the Pharmacokinetics (PK) of TAK-906 in Healthy Participants

NCT03161405 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2019-01-11

Study results available
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Summary

The purpose of this study is to evaluate the effect of the potent cytochrome P-450 (CYP) 3A4 inhibitor (itraconazole) on the single-dose PK of oral TAK-906 maleate.

Conditions

  • Healthy Participants

Interventions

DRUG

TAK-906 Maleate

TAK-906 capsule

DRUG

Itraconazole

Itraconazole solution

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director · Takeda

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-06-05
Primary Completion
2017-07-02
Completion
2017-07-10
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03161405 on ClinicalTrials.gov