Study Evaluating Drug Interaction Between Multiple Doses of Ketoconazole and a Single Dose of SKI-606

This study has been completed.

First Received: February 9, 2007 Last Updated: September 10, 2007 History of Changes

Sponsor:	Wyeth
Information provided by:	Wyeth
ClinicalTrials.gov Identifier:	NCT00434486

Purpose

To investigate a potential pharmacokinetic interaction between SKI-606 and ketoconazole when co-administered.

Condition	Intervention	Phase
Healthy	Drug: SKI-606	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Crossover Assignment, Pharmacokinetics Study
Official Title:	An Open-Label, Randomized, 2-Period Crossover Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Ketoconazole and a Single Dose of SKI-606 Administered Orally to Healthy Subjects

Resource links provided by NLM:

Drug Information available for: Ketoconazole Fungarest Bosutinib

Further study details as provided by Wyeth:

Primary Outcome Measures:

Estimated Enrollment:	24
Study Start Date:	March 2007
Estimated Study Completion Date:	March 2007

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: NCT00434486

Locations

United States, Pennsylvania

Philadelphia, Pennsylvania, United States, 19148

Sponsors and Collaborators

Wyeth

Investigators

Study Director:

Medical Monitor

Wyeth

More Information

No publications provided

Study ID Numbers:	3160A4-104
Study First Received:	February 9, 2007
Last Updated:	September 10, 2007
ClinicalTrials.gov Identifier:	NCT00434486 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Therapeutic Uses
Antifungal Agents
Ketoconazole
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010