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HKI-272 Ketoconazole Drug Interaction Study

NCT ID: NCT00380328

Last Updated: 2012-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2006-11-30

Brief Summary

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To investigate a potential pharmacokinetic drug interaction between HKI-272 and ketoconazole when co-administered.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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neratinib

HKI-272

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Puma Biotechnology, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Puma

Role: STUDY_DIRECTOR

Biotechnology

Other Identifiers

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3144A1-106

Identifier Type: -

Identifier Source: org_study_id

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