Study Evaluating SCA-136 Tolerability With Dose Titration and Food

This study has been terminated.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: January 8, 2007
Last updated: December 6, 2007
Last verified: December 2007

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 Intervention Phase
Drug: SCA-136
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

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

Estimated Enrollment: 120
Study Start Date: December 2006
Study Completion Date: December 2006

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy men or women, aged 18 to 50 years

Exclusion Criteria:

  • Abnormal vital signs, ECG, or lab results
  Contacts and Locations
Please refer to this study by its identifier: NCT00420706

United States, Florida
Miami, Florida, United States, 33126
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided Identifier: NCT00420706     History of Changes
Other Study ID Numbers: 3153A1-105
Study First Received: January 8, 2007
Last Updated: December 6, 2007
Health Authority: United States: Food and Drug Administration processed this record on April 17, 2014