Study Evaluating Oral Administrations of HKI-272 in Healthy Male Subjects

This study has been completed.
Information provided by (Responsible Party):
Puma Biotechnology, Inc. Identifier:
First received: October 25, 2007
Last updated: May 10, 2012
Last verified: May 2012

The purpose of this study is to evaluate the mass balance and metabolic distribution of C14-labeled HKI-272 in healthy male subjects.

Condition Intervention Phase
Drug: neratinib
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]-Labeled HKI-272 in Healthy Male Subjects

Further study details as provided by Puma Biotechnology, Inc.:

Primary Outcome Measures:
  • Mass balance, metabolic distribution, PK [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 6
Study Start Date: March 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
240 mg
Drug: neratinib
HKI-272, Single-dose capsule and solution


Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy male subjects, aged 18 to 50 years.

Exclusion Criteria:

  • Female subjects
  Contacts and Locations
Please refer to this study by its identifier: NCT00550212

Sponsors and Collaborators
Puma Biotechnology, Inc.
Study Director: Puma Biotechnology
  More Information

No publications provided

Responsible Party: Puma Biotechnology, Inc. Identifier: NCT00550212     History of Changes
Other Study ID Numbers: 3144A1-1108
Study First Received: October 25, 2007
Last Updated: May 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Puma Biotechnology, Inc.:
healthy subjects processed this record on April 17, 2014