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Effects of Fluconazole and Itraconazole CYP3A-Mediated Inhibition on the Pharmacokinetics, Safety, and Tolerability of MLN4924 in Participants With Advanced Solid Tumors

NCT02122770 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2019-01-07

Study results available
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Summary

The primary purpose of this study is to assess the effect of multiple-dose administration of fluconazole on the single-dose intravenous (IV) pharmacokinetics (PK) of MLN4924; and to assess the effect of multiple-dose administration of itraconazole on the single-dose IV PK of MLN4924.

Conditions

Interventions

DRUG

MLN4924

MLN4924 intravenous solution.

DRUG

Fluconazole

Fluconazole tablets.

DRUG

Itraconazole

Itraconazole oral solution.

DRUG

Docetaxel

Docetaxel intravenous solution.

DRUG

Carboplatin

Carboplatin intravenous solution.

DRUG

Paclitaxel

Paclitaxel intravenous solution.

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Director Clinical Science · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-01
Primary Completion
2017-06-05
Completion
2017-06-05

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT02122770 on ClinicalTrials.gov