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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00722306
First received: July 23, 2008
Last updated: February 3, 2011
Last verified: February 2011
  Purpose

To determine the mass balance of PD 0200390


Condition Intervention Phase
Insomnia
Drug: PD 0200390
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • % urinary recovery [ Time Frame: 2 days ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 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: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00722306     History of Changes
Other Study ID Numbers: A4251072
Study First Received: July 23, 2008
Last Updated: February 3, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
non-restorative
sleep

ClinicalTrials.gov processed this record on July 20, 2014