HKI-272 Ketoconazole Drug Interaction Study

Phase 1

Completed

• Conditions: Healthy

• Registration Number: NCT00380328
• Lead Sponsor: Puma Biotechnology, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-09-21
• Study First Submitted QC: 2006-09-22
• Study First Posted: 2006-09-25
• Study Start: 2006-10
• Study Completion: 2006-11
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-10
• Last Update Posted: 2012-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics; safety and tolerability