A First In Human Study Of PF-00184562 In Healthy Volunteers

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00150215
• Collaborator: PPD (Industry)
• Enrollment: 18
• Location: 1
• Duration (Months): 3
• Patients Per Site Per Month: 6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: PF-00184562; Drug: Olanzapine	Phase 1

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: An Oral, Rising Single-Dose Tolerance, Pharmacokinetic, and Pharmacodynamic Study of Pf-00184562 Capsules In Healthy Volunteers
• Study Start Date: Jul 1, 2005
• Study Completion Date: Oct 1, 2005

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability of single dose PF-00184562 as determined by: adverse event reporting, clinical laboratory results, vital signs, physical examinations, and electrocardiograms (ECGs). []

2. Pharmacokinetic profile of PF-00184562 maximum concentration (Cmax) []

3. Time to obtain maximum concentration (tmax), area under concentration-time curve (AUC), and terminal half-life (t1/2). []

4. Exposure-response relationship of neuropsychometric and tolerability measures of PF-00184562 compared to olanzapine. []

5. All measurements to be assessed over single doses. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Austin	Texas	United States	78744

Sponsors and Collaborators

• Pfizer
• PPD

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00150215
• Other Study ID Numbers: A6241001
• First Posted: Sep 8, 2005
• Last Update Posted: Jul 25, 2006
• Last Verified: Apr 1, 2006

• Additional relevant MeSH terms: Schizophrenia; Olanzapine

Study Results

No Results Posted as of Jul 25, 2006