NCT00550212
Completed
Phase 1
An Open-Label, Single-Dose Study of the Mass Balance and Metabolic Disposition of Orally Administered [14C]-Labeled HKI-272 in Healthy Male Subjects
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Puma Biotechnology, Inc.
- Enrollment
- 6
- Primary Endpoint
- Mass balance, metabolic distribution, PK
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Healthy male subjects, aged 18 to 50 years.
Exclusion Criteria
- •Female subjects
Arms & Interventions
1
Experimental
240 mg
Intervention: neratinib (Drug)
Outcomes
Primary Outcomes
Mass balance, metabolic distribution, PK
Time Frame: 10 days
Secondary Outcomes
No secondary outcomes reported
Investigators
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