A Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers

This study has been completed.

First Received: July 23, 2008 Last Updated: July 24, 2008 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00722306

Purpose

To determine the mass balance of PD 0200390

Condition	Intervention	Phase
Insomnia	Drug: PD 0200390	Phase I

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study
Official Title:	A Phase One Open-Label Single-Radiolabeled Dose Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers

Further study details as provided by Pfizer:

Primary Outcome Measures:

Radioactivity parameters in plasma and whole blood - Cmax , Tmax , AUCinf, AUClast, t1/2, CL/F and V/F and Total 14C data in blood, urine and feces [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Arms	Assigned Interventions
A425: Experimental A425 Treated	Drug: PD 0200390 Extemporaneous solution of C14 Labelled PD 0200390 60 mg single dose

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00722306

Locations

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A4251072
Study First Received:	July 23, 2008
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00722306 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

non-restorative
sleep

Study placed in the following topic categories:

Healthy

ClinicalTrials.gov processed this record on May 07, 2009