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A Phase 1 Study to Evaluate the Effects of Fluconazole and Atorvastatin on the Pharmacokinetics of TAK-385 in Healthy Subjects

NCT02093390 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2016-06-06

Study results available
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Summary

This is a nonrandomized, open-label, fixed-sequence, 2-arm study designed to assess the effect of multiple doses of fluconazole or atorvastatin on the single-dose pharmacokinetics of TAK-385 in healthy adult subjects.

Conditions

Interventions

DRUG

TAK-385

TAK-385 tablets

DRUG

Fluconazole

Fluconazole tablets

DRUG

Atorvastatin

Atorvastatin tablets

Sponsors & Collaborators

  • Millennium Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Millennium Pharmaceuticals, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-04-30
Completion
2014-04-30

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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 NCT02093390 on ClinicalTrials.gov