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

Puma Biotechnology

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: neratinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00550212

3144A1-1108

Details and patient eligibility

About

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

Enrollment: 6 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects, aged 18 to 50 years.

Exclusion criteria

• Female subjects

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

1

Experimental group

Description:

240 mg

Treatment:

Drug: neratinib