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

June 9, 2010
May 10, 2012
June 2010
September 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01142063 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects
A Single Dose Bioequivalence Study Comparing The Commercial Tablet Formulation To The Clinical Tablet 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.

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

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma

Probability Sample

Cohorts will be selected from healthy volunteers.

Healthy
Drug: Neratinib
Tablet, a 240 mg single oral dose
Other Name: HKI-272
  • 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.
    Intervention: Drug: Neratinib
  • 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.
    Intervention: Drug: Neratinib
  • 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.
    Intervention: Drug: Neratinib
  • 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.
    Intervention: Drug: Neratinib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
September 2010
September 2010   (final data collection date for primary outcome measure)

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).
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01142063
B1891021, 3144A1-1127
No
Puma Biotechnology, Inc.
Puma Biotechnology, Inc.
Not Provided
Study Director: Puma Biotechnology
Puma Biotechnology, Inc.
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP