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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.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00722306
First received: July 23, 2008
Last updated: February 3, 2011
Last verified: February 2011
History of Changes
  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
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:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

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 May 16, 2013