A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT01142063
First received: June 9, 2010
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Neratinib
Phase 1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Single Dose Bioequivalence Study Comparing The Commercial Tablet Formulation To The Clinical Tablet Of Neratinib In Healthy Subjects

Further study details as provided by Puma Biotechnology, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Plasma


Enrollment: 28
Study Start Date: June 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment A (Reference fasted)
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
Tablet, a 240 mg single oral dose
Other Name: HKI-272
Treatment B (Test fasted)
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
Tablet, a 240 mg single oral dose
Other Name: HKI-272
Treatment C (Reference fed)
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
Tablet, a 240 mg single oral dose
Other Name: HKI-272
Treatment D (Test fed)
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
Tablet, a 240 mg single oral dose
Other Name: HKI-272

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Cohorts will be selected from healthy volunteers.

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01142063

Locations
United States, Connecticut
Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
Study Director: Puma Biotechnology
  More Information

No publications provided

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT01142063     History of Changes
Other Study ID Numbers: B1891021, 3144A1-1127
Study First Received: June 9, 2010
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Puma Biotechnology, Inc.:
Neratinib

ClinicalTrials.gov processed this record on August 26, 2014