Study Evaluating TwoTablet Formulations of Neratinib (HKI-272)

Puma Biotechnology

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: neratinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00814060

3144A1-1117

Details and patient eligibility

About

This study will examine the bioavailability (the rate and extent to which the active ingredient or active moiety is absorbed from a drug product and becomes available at the site of action) of two tablet formulations of Neratinib (HKI-272) compared to the capsule formulation.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Healthy male and female subjects, ages 18-50.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

1

Experimental group

Description:

40-mg tablet

Treatment:

Drug: neratinib

2

Experimental group

Description:

240-mg tablet

Treatment:

Drug: neratinib

3

Experimental group

Description:

80-mg capsule

Treatment:

Drug: neratinib