A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

Puma Biotechnology

Status: Completed

Conditions: Healthy

Treatments: Drug: Neratinib

Study type: Observational

Funder types: Industry

Identifiers

NCT01142063

3144A1-1127

B1891021

Details and patient eligibility

About

The purpose of the study is to demonstrate the bioequivalence of the proposed commercial neratinib tablet formulation (240 mg strength x 1) to the reference Phase 3 tablet formulation (40 mg tablet strength x 6) under fed and fasted conditions in healthy subjects.

Full description

The study will be an open label, randomized, 4 period, 4 treatment, 4 sequence (Williams design), cross over.

Enrollment: 28 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• An informed consent document signed and dated by the subject or a legally acceptable representative.
• Healthy male and/or female of non-childbearing potential subjects between the ages of 18 and 55 years, inclusive (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG, and clinical laboratory tests).

Exclusion criteria

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
• Any condition possibly affecting drug absorption (eg, gastrectomy).

Trial design

28 participants in 4 patient groups

Treatment A (Reference fasted)

Description:

Treatment A (Reference fasted): A 40 mg tablet strength neratinib administered as a single dose of 6 x 40 mg under fasted condition.

Treatment:

Drug: Neratinib

Drug: Neratinib

Drug: Neratinib

Drug: Neratinib

Treatment B (Test fasted)

Description:

Treatment B (Test fasted): A 240 mg tablet strength neratinib administered as a single dose of 1 x 240 mg under fasted condition.

Treatment:

Drug: Neratinib

Drug: Neratinib

Drug: Neratinib

Drug: Neratinib

Treatment C (Reference fed)

Description:

Treatment C (Reference fed): A 40 mg tablet strength neratinib administered as a single dose of 6 x 40 mg under fed condition.

Treatment:

Drug: Neratinib

Drug: Neratinib

Drug: Neratinib

Drug: Neratinib

Treatment D (Test fed)

Description:

Treatment D (Test fed): A 240 mg tablet strength neratinib administered as a single dose of 1 x 240 mg under fed condition.

Treatment:

Drug: Neratinib

Drug: Neratinib

Drug: Neratinib

Drug: Neratinib