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

An Open-Label, Single-Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]-Labeled HKI-272 in Healthy Male Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00550212

Enrollment

Registered

2007-10-29

Start date

2008-03-31

Completion date

2008-04-30

Last updated

2012-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

healthy subjects

Brief summary

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

Interventions

DRUGneratinib

HKI-272, Single-dose capsule and solution

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male subjects, aged 18 to 50 years.

Exclusion criteria

* Female subjects

Design outcomes

Primary

Measure	Time frame
Mass balance, metabolic distribution, PK	10 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026