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

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

Completed

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Key information

Conditions

Healthy

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Healthy male subjects, aged 18 to 50 years.

Exclusion criteria

Female subjects

Treatment and study plan

Neratinib

Drug

HKI-272, Single-dose capsule and solution

Primary outcomes

Mass balance, metabolic distribution, PK

Time frame: 10 days

Sponsors and collaborators

Lead sponsor

Puma Biotechnology, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Oct 29, 2007
Registry last updated: May 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed