Expired Study
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New Haven, Connecticut 06511


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.


Study summary:

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


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).


Study is Available At:


Original ID:

B1891021


NCT ID:

NCT01142063


Secondary ID:

3144A1-1127


Study Acronym:


Brief Title:

A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Puma Biotechnology, Inc.


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:

Observational Model: Cohort, Time Perspective: P


Number of Arms:

0


Number of Groups:

4


Total Enrollment:

28


Enrollment Type:

Actual


Overall Contact Information

Official Name:Puma
Study Director
Biotechnology

Study Dates

Start Date:June 2010
Completion Date:September 2010
Completion Type:Actual
Primary Completion Date:September 2010
Primary Completion Type:Actual
Verification Date:May 2012
Last Changed Date:May 10, 2012
First Received Date:June 9, 2010

Study Outcomes

Outcome Type: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
Safety Issues:False
Outcome Type:Secondary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Neratinib
Description:Tablet, a 240 mg single oral dose
Arm Name:Treatment D (Test fed)
Other Name:HKI-272
Intervention Type:Drug
Name:Neratinib
Description:Tablet, a 240 mg single oral dose
Arm Name:Treatment C (Reference fed)
Other Name:HKI-272
Intervention Type:Drug
Name:Neratinib
Description:Tablet, a 240 mg single oral dose
Arm Name:Treatment B (Test fasted)
Other Name:HKI-272
Intervention Type:Drug
Name:Neratinib
Description:Tablet, a 240 mg single oral dose
Arm Name:Treatment A (Reference fasted)
Other Name:HKI-272

Study Arms

Study Arm Type:Other
Arm Name:Treatment A (Reference fasted)
Description:Treatment A (Reference fasted): A 40 mg tablet strength neratinib administered as a single dose of 6 x 40 mg under fasted condition.
Study Arm Type:Other
Arm Name:Treatment B (Test fasted)
Description:Treatment B (Test fasted): A 240 mg tablet strength neratinib administered as a single dose of 1 x 240 mg under fasted condition.
Study Arm Type:Other
Arm Name:Treatment C (Reference fed)
Description:Treatment C (Reference fed): A 40 mg tablet strength neratinib administered as a single dose of 6 x 40 mg under fed condition.
Study Arm Type:Other
Arm Name:Treatment D (Test fed)
Description:Treatment D (Test fed): A 240 mg tablet strength neratinib administered as a single dose of 1 x 240 mg under fed condition.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Puma Biotechnology, Inc.

Samples and Retentions

Sample Retention:Samples Without DNA
Description: Plasma
Study Population: Cohorts will be selected from healthy volunteers.
Sample Method:Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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