A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis
NCT00730145
Last updated date
ABOUT THIS STUDY
1. Quantify how much PD-0332334 is removed from the blood with hemodialysis
2. Investigate the pharmacokinetics of a single dose of PD-0332334 in subjects receiving
regular hemodialysis treatments.
3. Investigate the safety and tolerability of a single dose of PD-0332334 in subjects
receiving hemodialysis.
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
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Dialysis, Pharmacokinetics
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Patients receiving regular hemodialysis
- Male or female patients 18 to 65 years
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Severe heart failure
- Renal transplant or renal allograft
- Illicit drug use (with the exception of prescribed sedatives)
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Renal Dialysis, PharmacokineticsA Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis
NCT00730145
- Orlando, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Single Dose Study Investigating The Elimination Of PD-0332334 In Patients Receiving Regular Hemodialysis | |||
| Official Title ICMJE | A Phase I, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD-0332334 In Subjects Receiving Chronic Hemodialysis | |||
| Brief Summary |
| |||
| Detailed Description | Assess the elimination of PD-0332334 from the blood with hemodialysis | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) | |||
| Condition ICMJE |
| |||
| Intervention ICMJE | Drug: PD-0332334
A single, 50 mg oral dose (2 capsules) of PD-0332334 will be administered to each hemodialysis subject Other Name: imagabalin | |||
| Study Arms ICMJE | Experimental: PD-0332334
Intervention: Drug: PD-0332334 | |||
| 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 | 8 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | January 2009 | |||
| Actual Primary Completion Date | January 2009 (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 | No | |||
| 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 | NCT00730145 | |||
| Other Study ID Numbers ICMJE | A5361032 | |||
| 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 2010 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||