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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: July 23, 2008
Last updated: February 3, 2011
Last verified: February 2011
To determine the mass balance of PD 0200390

Condition Intervention Phase
Drug: PD 0200390
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

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 ]

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

Enrollment: 6
Study Start Date: May 2008
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A425
A425 Treated
Drug: PD 0200390
Extemporaneous solution of C14 Labelled PD 0200390 60 mg single dose


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

Inclusion Criteria:

  • Healthy

Exclusion Criteria:

  • unhealthy, or concomitant meds
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00722306

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00722306     History of Changes
Other Study ID Numbers: A4251072
Study First Received: July 23, 2008
Last Updated: February 3, 2011

Keywords provided by Pfizer:
sleep processed this record on April 28, 2017