Study Evaluating The Effect Of A High-Fat Meal On The Pharmacokinetics Of Neratinib

Puma Biotechnology

Status and phase: Withdrawn; Phase 1

Conditions: Healthy

Treatments: Drug: Neratinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00932464

3144A2-1112

B1891007

Details and patient eligibility

About

This study is being conducted to see if neratinib is absorbed, distributed, or eliminated differently when administered in the fasting state versus after a high-fat meal.

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and women of nonchildbearing potential, age 18 to 50 years.

Exclusion criteria

• Any previous or current clinically significant medical condition or disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

1

Experimental group

Description:

Neratinib Fasted

Treatment:

Drug: Neratinib

Drug: Neratinib

2

Experimental group

Description:

Neratinib Fed

Treatment:

Drug: Neratinib

Drug: Neratinib