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Comparative Formulation Study of Vabicaserin

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00928551
First received: June 24, 2009
Last updated: September 10, 2009
Last verified: September 2009
  Purpose

This study will compare two different formulations of vabicaserin.


Condition Intervention Phase
Healthy Subjects
Drug: vabicaserin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Single-Dose, 3-Period Crossover, Comparative Study of a Modified Formulation of Vabicaserin (SCA-136) Versus the Reference Formulation in Healthy Subjects

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

Primary Outcome Measures:
  • Pharmacokinetic parameters including plasma concentrations, Cmax, and AUC. [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety assessment as measured by evaluating any reported adverse events, scheduled physical examinations, vital sign measurements, ECGs, and clinical laboratory results. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 15
Study Start Date: June 2009
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: vabicaserin

  Eligibility

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

Inclusion Criteria:

  • Sexually active men must agree to use a medically acceptable form of contraception during the study and continue it for 12 weeks after investigational product administration.
  • Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.

Exclusion Criteria:

  • Use of any investigational or prescription drug within 30 days before investigation product administration.
  • Consumption of any caffeine-containing products (eg, coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1.
  • Use of any over-the-counter drugs, including herbal supplements within 72 hours before study day 1.
  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: NCT00928551

Locations
United States, Massachusetts
Brighton, Massachusetts, United States, 2135
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

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00928551     History of Changes
Other Study ID Numbers: 3153B3-1128
Study First Received: June 24, 2009
Last Updated: September 10, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on November 20, 2014