Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00541996
Previous Study | Return to List | Next Study

Study Comparing Bioavailability of Oral Formulations of Vabicaserin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00541996
Recruitment Status : Completed
First Posted : October 10, 2007
Last Update Posted : December 5, 2007
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE October 5, 2007
First Posted Date  ICMJE October 10, 2007
Last Update Posted Date December 5, 2007
Study Start Date  ICMJE August 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2007)
Assess the bioavailability of four oral formulations of vabicaserin.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00541996 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2007)
Obtain additional safety and tolerability data for vabicaserin in healthy male subjects.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Comparing Bioavailability of Oral Formulations of Vabicaserin
Official Title  ICMJE A Randomized, Open-Label, Single-Dose, 4-Period Crossover, Comparative Bioavailability Study of 3 Sustained- Release Formulations and an Immediate- Release Formulation of Vabicaserin (SCA-136) in Healthy Subjects
Brief Summary The purpose of this study is to determine the absorption rate of four oral formulations of vabicaserin.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: vabicaserin
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 Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy men aged 18-50 years.

Exclusion Criteria:

  • Any significant disease state.
  • History of drug or alcohol abuse within 1 year.
  • Abnormal liver function tests.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
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 NCT00541996
Other Study ID Numbers  ICMJE 3153A1-1116
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
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
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