- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00406406
Study Evaluating SKI-606 Administered to Healthy Subjects
December 3, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
Ascending Single Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SKI-606 Administered Orally to Healthy Subjects
Safety and tolerability of SKI-606 in healthy subjects; the influence of food intake on the same.
Study Overview
Study Type
Interventional
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Utrecht, Netherlands, 3584 CJ
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Pharmacokinetics; safety and tolerability; influence of food.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Study Completion (Actual)
August 1, 2007
Study Registration Dates
First Submitted
November 29, 2006
First Submitted That Met QC Criteria
November 30, 2006
First Posted (Estimate)
December 4, 2006
Study Record Updates
Last Update Posted (Estimate)
December 5, 2007
Last Update Submitted That Met QC Criteria
December 3, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- 3160A1-103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Wyeth is now a wholly owned subsidiary of PfizerCompleted
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Wyeth is now a wholly owned subsidiary of PfizerCompleted
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PfizerCompletedChronic Myeloid LeukemiaUnited States, Spain, Australia, Canada, Hong Kong, Singapore, United Kingdom, Germany, Netherlands, Chile, India, South Africa, Sweden, Peru, Argentina, Italy, Austria, Colombia, Brazil, China, Finland, Hungary, Korea, Republic of, M... and more