Study Comparing 2 New Formulations of HKI-272 in Healthy Adult Subjects

Puma Biotechnology, Inc.36 enrolled

Overview

To evaluate the comparative bioavailability of 2 new tablet formulations of HKI-272 with a reference capsule and an oral solution in healthy subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

neratinibDRUG

HKI-272

Eligibility

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

Medical Language ↔ Plain English

Criteria: * Healthy male and female subjects aged 18 to 50 years. * Women of nonchildbearing potential (WONCBP)

Locations (1)

Unnamed facility

San Antonio, Texas, United States

Outcomes

Primary Outcomes

The data from this study along with in vitro data will be used to explore in vitro/in vivo correlation for HKI-272 to support formulation development.

Data from ClinicalTrials.gov

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