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Please see Detailed Description for termination reason.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1-Normal | Experimental |
| |
| Group 2-Mild | Experimental |
| |
| Group 3-Moderate | Experimental |
| |
| Group 4-Severe | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD 0332334 | Drug | 50 mg (two 25 mg capsules), single, oral dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F) | 1 day | |
| amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96) | 5 days | |
| PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast), | 5 to 17 days depending on cohort | |
| PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2), | 5 to 17 days depending on cohort |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs | 5 to 17 days |
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Inclusion Criteria:
Healthy volunteers OR subjects with kidney impairment
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Cypress | California | 90630 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| PD 0332334 | Drug | 50 mg (two 25 mg capsules), single, oral dose |
|
| PD 0332334 | Drug | 50 mg (two 25 mg capsules), single, oral dose |
|
| PD 0332334 | Drug | 50 mg (two 25 mg capsules), single, oral dose |
|
| Miami |
| Florida |
| 33169 |
| United States |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C583768 | imagabalin |
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