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Study Comparing Bioavailability of Oral Formulations of Vabicaserin

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00541996
Enrollment
Unknown
Registered
2007-10-10
Start date
2007-08-31
Completion date
2007-10-31
Last updated
2007-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief summary

The purpose of this study is to determine the absorption rate of four oral formulations of vabicaserin.

Interventions

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Assess the bioavailability of four oral formulations of vabicaserin.

Secondary

MeasureTime frame
Obtain additional safety and tolerability data for vabicaserin in healthy male subjects.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026