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Study Evaluating 3 New Formulations of SKI-606 in Healthy Adult Subjects

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00499538
First Posted: July 11, 2007
Last Update Posted: December 27, 2007
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.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
  Purpose
To evaluate the comparative bioavailability of 3 new tablet formulations of SKI-606 with a reference capsule and an oral solution in healthy subjects.

Condition Intervention Phase
Healthy Drug: SKI-606 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: A Single Dose Bioavailability Study of 3 New Formulations of SKI-606 (500 mg) Compared With a Reference Capsule and an Oral Solution in Healthy Adult Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The data from this study along with in vitro data will be used to explore in vitro/in vivo correlation for SKI-606 to support formulation development.

Estimated Enrollment: 40
Study Start Date: July 2007
Study Completion Date: September 2007
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Criteria:

  • Healthy male and female aged 18 to 50 years.
  • Women of nonchildbearing potential (WONCBP).
  Contacts and Locations
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): NCT00499538


Locations
United States, Texas
San Antonio, Texas, United States, 78217
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

ClinicalTrials.gov Identifier: NCT00499538     History of Changes
Other Study ID Numbers: 3160A4-1109
First Submitted: July 9, 2007
First Posted: July 11, 2007
Last Update Posted: December 27, 2007
Last Verified: December 2007

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
healthy subjects