A First In Human Study Of PF-00184562 In Healthy Volunteers
Phase 1
Completed
- Conditions
- Schizophrenia
- Registration Number
- NCT00150215
- Lead Sponsor
- Pfizer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
Inclusion Criteria
- Healthy male or female subjects of non-childbearing potential
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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).
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Austin, Texas, United States