A Single Dose Study Investigating the Elimination as Well as the Tolerability of PD 0332334 in Healthy Subjects as Compared to Patients With Impaired Kidney Function.
This study has been terminated.
(Please see Detailed Description for termination reason.)
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00721422
First received: July 22, 2008
Last updated: February 16, 2010
Last verified: February 2010
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Purpose
- To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body.
- To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Insufficiency Pharmacokinetics |
Drug: PD 0332334 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | A Phase 1, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD 0332334 In Subjects With Various Degrees Of Renal Function |
Further study details as provided by Pfizer:
Primary Outcome Measures:
- maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
- amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
- PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast), [ Time Frame: 5 to 17 days depending on cohort ] [ Designated as safety issue: No ]
- PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2), [ Time Frame: 5 to 17 days depending on cohort ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs [ Time Frame: 5 to 17 days ] [ Designated as safety issue: Yes ]
| Enrollment: | 16 |
| Study Start Date: | August 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group 1-Normal |
Drug: PD 0332334
50 mg (two 25 mg capsules), single, oral dose
Other Name: imagabalin
|
| Experimental: Group 2-Mild |
Drug: PD 0332334
50 mg (two 25 mg capsules), single, oral dose
|
| Experimental: Group 3-Moderate |
Drug: PD 0332334
50 mg (two 25 mg capsules), single, oral dose
|
| Experimental: Group 4-Severe |
Drug: PD 0332334
50 mg (two 25 mg capsules), single, oral dose
|
Detailed Description:
Additional Study Purpose Details: Investigation of the pharmacokinetics, safety, and tolerability of a single dose of PD 0332334 in patients with impaired renal function.
On February 23rd 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Healthy volunteers OR subjects with kidney impairment
Exclusion Criteria:
- Receiving hemodialysis
- clinically significant or unstable medical disease other than kidney disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721422
Locations
| United States, California | |
| Pfizer Investigational Site | |
| Cypress, California, United States, 90630 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Miami, Florida, United States, 33169 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
| ClinicalTrials.gov Identifier: | NCT00721422 History of Changes |
| Other Study ID Numbers: | A5361023 |
| Study First Received: | July 22, 2008 |
| Last Updated: | February 16, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
Pharmacokinetics of PD 0332334 in subjects with renal insufficiency |
Additional relevant MeSH terms:
|
Renal Insufficiency Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 21, 2013