Study Evaluating SCA-136 Tolerability With Dose Titration and Food

This study has been terminated.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00420706
First received: January 8, 2007
Last updated: December 6, 2007
Last verified: December 2007
  Purpose

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
Healthy
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
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on September 16, 2014