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NCT00420706 Clinical Trial

Study Evaluating SCA-136 Tolerability With Dose Titration and Food

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00420706
Other study ID # 3153A1-105
Secondary ID
Status Terminated
Phase Phase 1
First received January 8, 2007
Last updated December 6, 2007
Start date December 2006
Est. completion date December 2006

Study information
Verified date December 2007
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 120
Est. completion date December 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Healthy men or women, aged 18 to 50 years

Exclusion Criteria:

- Abnormal vital signs, ECG, or lab results

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• SCA-136

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The primary endpoint is the proportion of subjects reporting nausea (based on AEs) over the dosing period.
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