HKI-272 Ketoconazole Drug Interaction Study

Puma Biotechnology

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: neratinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00380328

3144A1-106

Details and patient eligibility

About

To investigate a potential pharmacokinetic drug interaction between HKI-272 and ketoconazole when co-administered.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead ECG.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)