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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A Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers
NCT00722306
Last updated on November 14, 2019
About this Study
To determine the mass balance of PD 0200390
NCT00722306
Pfizer
Completed
A Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0200390 In Six Healthy Male Volunteers
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| 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 | ||||
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