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A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01142063
First Posted: June 11, 2010
Last Update Posted: May 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
  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

Resource links provided by NLM:


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 ]

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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT01142063     History of Changes
Other Study ID Numbers: B1891021
3144A1-1127
First Submitted: June 9, 2010
First Posted: June 11, 2010
Last Update Posted: May 14, 2012
Last Verified: May 2012

Keywords provided by Puma Biotechnology, Inc.:
Neratinib