HKI-272 Ketoconazole Drug Interaction Study

This study has been completed.

First Received: September 21, 2006 Last Updated: December 7, 2006 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00380328

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: HKI-272	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment
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

Resource links provided by NLM:

Drug Information available for: Ketoconazole Fungarest HKI-272

Further study details as provided by Wyeth:

Primary Outcome Measures:

Study Start Date:	October 2006
Estimated Study Completion Date:	October 2006

Eligibility

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380328

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3144A1-106
Study First Received:	September 21, 2006
Last Updated:	December 7, 2006
ClinicalTrials.gov Identifier:	NCT00380328 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Wyeth:

Pharmacokinetic
healthy subjects

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Ketoconazole
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2009