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
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 April 17, 2014