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HKI-272 Ketoconazole Drug Interaction Study

Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy

Intervention: HKI-272 (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

Summary

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

Clinical Details

Official title: An Open-Label, Randomized, 2-Period Crossover, Drug Interaction Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Ketoconazole and a Single Dose of HKI-272 Administered Orally to Healthy Subjects

Study design: Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment

Primary outcome: Pharmacokinetics; safety and tolerability

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: October 2006
Ending date: October 2006
Last updated: December 7, 2006

Page last updated: June 20, 2008

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