Study Evaluating SCA-136 Tolerability With Dose Titration and Food
NCT00420706
Last updated date
ABOUT THIS STUDY
To evaluate whether the tolerability of SCA-136 is improved by dosing with food or by
increasing dose amounts in a step-wise fashion.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Healthy
Sex
Females and Males
Age
18-50 years
Inclusion Criteria
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- Healthy men or women, aged 18 to 50 years
Exclusion Criteria
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- Abnormal vital signs, ECG, or lab results
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Study Evaluating SCA-136 Tolerability With Dose Titration and Food | |||
Official Title ICMJE | 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 | |||
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. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE | Drug: SCA-136 | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Enrollment ICMJE | 120 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | December 2006 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00420706 | |||
Other Study ID Numbers ICMJE | 3153A1-105 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | December 2007 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |