A First In Human Study Of PF-00184562 In Healthy Volunteers
This study has been completed.
Information provided by:
First received: September 6, 2005
Last updated: July 24, 2006
Last verified: April 2006
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||An Oral, Rising Single-Dose Tolerance, Pharmacokinetic, and Pharmacodynamic Study of Pf-00184562 Capsules In Healthy Volunteers|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- 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.
|Study Start Date:||July 2005|
|Estimated Study Completion Date:||October 2005|
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