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Study Evaluating SCA-136 Tolerability With Dose Titration and Food

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ClinicalTrials.gov Identifier: NCT00420706
Recruitment Status : Terminated
First Posted : January 11, 2007
Last Update Posted : December 10, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary:
To evaluate whether the tolerability of SCA-136 is improved by dosing with food or by increasing dose amounts in a step-wise fashion.

Condition or disease Intervention/treatment Phase
Healthy Drug: SCA-136 Phase 1

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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
Study Start Date : December 2006
Actual Study Completion Date : December 2006



Primary Outcome Measures :
  1. The primary endpoint is the proportion of subjects reporting nausea (based on AEs) over the dosing period.


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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 men or women, aged 18 to 50 years

Exclusion Criteria:

  • Abnormal vital signs, ECG, or lab results

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): NCT00420706


Locations
United States, Florida
Miami, Florida, United States, 33126
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

ClinicalTrials.gov Identifier: NCT00420706     History of Changes
Other Study ID Numbers: 3153A1-105
First Posted: January 11, 2007    Key Record Dates
Last Update Posted: December 10, 2007
Last Verified: December 2007