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NCT00722306 Clinical Trial

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

Insomnia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00722306
Other study ID # A4251072
Secondary ID
Status Completed
Phase Phase 1
First received July 23, 2008
Last updated February 3, 2011
Start date May 2008
Est. completion date May 2008

Study information
Verified date February 2011
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

To determine the mass balance of PD 0200390

Recruitment information / eligibility
Status Completed
Enrollment 6
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Healthy

Exclusion Criteria:

- unhealthy, or concomitant meds

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• PD 0200390
Extemporaneous solution of C14 Labelled PD 0200390 60 mg single dose

Locations
Country Name City State
United States Pfizer Investigational Site New Haven Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 2 days No
Secondary % urinary recovery 2 days No
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