A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects
This study has been completed.
Sponsor:
Puma Biotechnology, Inc.
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
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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 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 June 13, 2013