A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

Completed

• Conditions: Healthy
• Interventions: Drug: Neratinib

• Registration Number: NCT01142063
• Lead Sponsor: Puma Biotechnology, Inc.

Brief Summary

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

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

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-09
• Study First Submitted QC: 2010-06-09
• Study First Posted: 2010-06-11
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment A (Reference fasted)	Neratinib	Treatment A (Reference fasted): A 40 mg tablet strength neratinib administered as a single dose of 6 x 40 mg under fasted condition.
Treatment B (Test fasted)	Neratinib	Treatment B (Test fasted): A 240 mg tablet strength neratinib administered as a single dose of 1 x 240 mg under fasted condition.
Treatment C (Reference fed)	Neratinib	Treatment C (Reference fed): A 40 mg tablet strength neratinib administered as a single dose of 6 x 40 mg under fed condition.
Treatment D (Test fed)	Neratinib	Treatment D (Test fed): A 240 mg tablet strength neratinib administered as a single dose of 1 x 240 mg under fed condition.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Investigational Site; 🇺🇸 New Haven, Connecticut, United States