A Single Dose Bioequivalence Study Of Neratinib In Healthy Subjects

NCT01142063 | Completed

• 2 other identifiers: B18910213144A1-1127
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Neratinib

Outcome Measures

Primary Outcomes (1)

• Maximum plasma concentration (Cmax) and Area under the plasma concentration-time profile from time zero extrapolated to infinite time for neratinib (AUCinf)

  0 to 48 hour post-dose

Secondary Outcomes (1)

• 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

  0 to 48 hour post-dose

Study Arms (4)

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

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

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

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

Interventions

Neratinib DRUG

Tablet, a 240 mg single oral dose

Also known as: HKI-272

Treatment A (Reference fasted)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Cohorts will be selected from healthy volunteers.

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Puma Biotechnology, Inc.: lead

Study Sites (1)

Investigational Site

New Haven, Connecticut, 06511, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Interventions

neratinib

Study Officials

• Puma

  Biotechnology

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2010
• First Posted: June 11, 2010
• Study Start: June 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: May 14, 2012

Record last verified: 2012-05

Locations

US (1)