A Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers
NCT00722306
Last updated date
ABOUT THIS STUDY
To determine the mass balance of PD 0200390
Study Location
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Insomnia
Sex
Females and Males
Age
18-65 years
Inclusion Criteria
Show details
- Healthy
Exclusion Criteria
Show details
- unhealthy, or concomitant meds
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | A Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers | |||
Official Title ICMJE | 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 | |||
Brief Summary | To determine the mass balance of PD 0200390 | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Insomnia | |||
Intervention ICMJE | Drug: PD 0200390
Extemporaneous solution of C14 Labelled PD 0200390 60 mg single dose | |||
Study Arms ICMJE | Experimental: A425
A425 Treated Intervention: Drug: PD 0200390 | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 6 | |||
Original Actual Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | May 2008 | |||
Actual Primary Completion Date | May 2008 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00722306 | |||
Other Study ID Numbers ICMJE | A4251072 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | February 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |