HKI-272 Ketoconazole Drug Interaction Study

Phase 1CompletedNCT00380328

Puma Biotechnology, Inc.24 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

neratinibDRUG

HKI-272

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Pharmacokinetics; safety and tolerability

Data from ClinicalTrials.gov

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