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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier:
NCT00550212
First received: October 25, 2007
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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
Healthy
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

  Eligibility

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

Inclusion Criteria:

  • Healthy male subjects, aged 18 to 50 years.

Exclusion Criteria:

  • Female subjects
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00550212

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

No publications provided

Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on July 29, 2014