Schizophrenia
Conditions
Brief summary
The purposes of this study are: * To determine the safety, tolerability and pharmacokinetics of single doses of PF-00184562; and * To explore the exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine.
Interventions
DRUGPF-00184562
DRUGOlanzapine
Sponsors
PPD Development, LP
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy male or female subjects of non-childbearing potential
Exclusion criteria
* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, pancreatic, psychiatric, neurologic, active infections, immunological, or allergic disease (including drug allergies and seasonal allergies at time of dosing).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability of single dose PF-00184562 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs). | — |
| Pharmacokinetic profile of PF-00184562 maximum concentration (Cmax) | — |
| Time to obtain maximum concentration (tmax), area under concentration-time curve (AUC), and terminal half-life (t1/2). | — |
| Exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine. | — |
| All measurements to be assessed over single doses. | — |
Countries
United States
Outcome results
None listed