A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

Study Overview
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Brief Summary
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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.

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

Official Title
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A Single Dose Bioequivalence Study Comparing The Commercial Tablet Formulation To The Clinical Tablet Of Neratinib In Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Neratinib
* Drug: Neratinib
* Drug: Neratinib
* Drug: Neratinib


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment A (Reference fasted)<br>Treatment A (Reference fasted): A 40 mg tablet strength neratinib administered as a single dose of 6 x 40 mg under fasted condition. | Drug: Neratinib<br>* Tablet, a 240 mg single oral dose<br>* Other names: HKI-272;|
| Treatment B (Test fasted)<br>Treatment B (Test fasted): A 240 mg tablet strength neratinib administered as a single dose of 1 x 240 mg under fasted condition. | Drug: Neratinib<br>* Tablet, a 240 mg single oral dose<br>* Other names: HKI-272;|
| Treatment C (Reference fed)<br>Treatment C (Reference fed): A 40 mg tablet strength neratinib administered as a single dose of 6 x 40 mg under fed condition. | Drug: Neratinib<br>* Tablet, a 240 mg single oral dose<br>* Other names: HKI-272;|
| Treatment D (Test fed)<br>Treatment D (Test fed): A 240 mg tablet strength neratinib administered as a single dose of 1 x 240 mg under fed condition. | Drug: Neratinib<br>* Tablet, a 240 mg single oral dose<br>* Other names: HKI-272;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) and Area under the plasma concentration-time profile from time zero extrapolated to infinite time for neratinib (AUCinf) |  | 0 to 48 hour post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Time for Cmax (Tmax), Area under the plasma concentration-time profile from time zero to the time of the last quantifiable concentration (Clast) (AUClast) and Terminal elimination half-life (t1/2) for neratinib |  | 0 to 48 hour post-dose | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Neratinib