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Completed

NCT Number: NCT01142063

A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Investigational Site

New Haven, Connecticut, 06511, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Neratinib

Drug

Tablet, a 240 mg single oral dose

Other names: HKI-272

Primary outcomes

  1. Maximum plasma concentration (Cmax) and Area under the plasma concentration-time profile from time zero extrapolated to infinite time for neratinib (AUCinf)

    Time frame: 0 to 48 hour post-dose

Secondary outcomes

  1. 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

    Time frame: 0 to 48 hour post-dose

Sponsors and collaborators

Lead sponsor

Puma Biotechnology, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 11, 2010
Registry last updated
May 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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