Comparative Formulation Study of Vabicaserin

Wyeth

Status and phase: Completed; Phase 1

Conditions: Healthy Subjects

Treatments: Drug: vabicaserin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00928551

3153B3-1128

Details and patient eligibility

About

This study will compare two different formulations of vabicaserin.

Enrollment: 15 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 1 patient group

1

Experimental group

Treatment:

Drug: vabicaserin