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Study Evaluating SKI-606 Administered to Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00406406
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : December 5, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
Safety and tolerability of SKI-606 in healthy subjects; the influence of food intake on the same.

Condition or disease Intervention/treatment Phase
Healthy Drug: SKI-606 Phase 1

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SKI-606 Administered Orally to Healthy Subjects
Study Start Date : November 2006
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Bosutinib
U.S. FDA Resources




Primary Outcome Measures :
  1. Pharmacokinetics; safety and tolerability; influence of food.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00406406


Locations
Netherlands
Utrecht, Netherlands, 3584 CJ
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
Principal Investigator: Trial Manager For Netherlands, trials-NL@wyeth.com

ClinicalTrials.gov Identifier: NCT00406406     History of Changes
Other Study ID Numbers: 3160A1-103
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: December 5, 2007
Last Verified: December 2007