- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00420706
Study Evaluating SCA-136 Tolerability With Dose Titration and Food
December 6, 2007 updated by: Wyeth is now a wholly owned subsidiary of Pfizer
A Multi-Dose, Double-Blind, Parallel-Group Study of the Effects of Dose Titration and Administration With Food on the Tolerability of SCA-136 in Healthy Subjects
To evaluate whether the tolerability of SCA-136 is improved by dosing with food or by increasing dose amounts in a step-wise fashion.
Study Overview
Study Type
Interventional
Enrollment
120
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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Florida
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Miami, Florida, United States, 33126
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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 men or women, aged 18 to 50 years
Exclusion Criteria:
- Abnormal vital signs, ECG, or lab results
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: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary endpoint is the proportion of subjects reporting nausea (based on AEs) over the dosing period.
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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
December 1, 2006
Study Completion (Actual)
December 1, 2006
Study Registration Dates
First Submitted
January 8, 2007
First Submitted That Met QC Criteria
January 9, 2007
First Posted (Estimate)
January 11, 2007
Study Record Updates
Last Update Posted (Estimate)
December 10, 2007
Last Update Submitted That Met QC Criteria
December 6, 2007
Last Verified
December 1, 2007
More Information
Terms related to this study
Other Study ID Numbers
- 3153A1-105
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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