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

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ClinicalTrials.gov Identifier: NCT00722306
Recruitment Status : Completed
First Posted : July 25, 2008
Last Update Posted : February 4, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
To determine the mass balance of PD 0200390

Condition or disease Intervention/treatment Phase
Insomnia Drug: PD 0200390 Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2008
Primary Completion Date : May 2008
Study Completion Date : May 2008
Arms and Interventions

Arm Intervention/treatment
Experimental: A425
A425 Treated
Drug: PD 0200390
Extemporaneous solution of C14 Labelled PD 0200390 60 mg single dose


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. % urinary recovery [ Time Frame: 2 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • unhealthy, or concomitant meds
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00722306     History of Changes
Other Study ID Numbers: A4251072
First Posted: July 25, 2008    Key Record Dates
Last Update Posted: February 4, 2011
Last Verified: February 2011

Keywords provided by Pfizer:
non-restorative
sleep