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

This study has been completed.

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

Sponsor:	Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:	Wyeth is now a wholly owned subsidiary of Pfizer
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:	Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
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:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Ketoconazole Fungarest Bosutinib

U.S. FDA Resources

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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 is now a wholly owned subsidiary of Pfizer

Investigators

Study Director:

Medical Monitor

Wyeth is now a wholly owned subsidiary of Pfizer

More Information

No publications provided

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

Additional relevant MeSH terms:

Ketoconazole
14-alpha Demethylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

Pharmacologic Actions
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012