Healthy Subjects
Conditions
Brief summary
This study will compare two different formulations of vabicaserin.
Interventions
DRUGvabicaserin
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters including plasma concentrations, Cmax, and AUC. | 2 months |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessment as measured by evaluating any reported adverse events, scheduled physical examinations, vital sign measurements, ECGs, and clinical laboratory results. | 2 months |
Countries
United States
Outcome results
None listed