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The study was prematurely terminated on 17th December 2014 due to safety concerns.
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The purpose of this study in healthy elderly people is to evaluate safety, toleration and time course of plasma concentration of multiple oral doses of PF-06743649- The pharmacodynamic activity of PF-06743649 will also be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1-PF-06743649 or placebo | Experimental |
| |
| Cohort 2-PF-06743649 or placebo | Experimental |
| |
| Cohort 3-PF-06743649 or placebo | Experimental |
| |
| Cohort 4-PF-06743649 or placebo | Experimental |
| |
| Cohort 5-PF-06743649 or placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06743649 | Drug | 20 mg tablet once daily dosing for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | up to 14 days | |
| Area Under the Curve from Time Zero to end of dosing interval (AUCtau) | up to 14 days | |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | up to 14 days | |
| Plasma Decay Half-Life (t1/2) | up to 14 days | |
| Amount of drug recovered unchanged in urine during the dosing interval (Aetau) | up to 14 days | |
| Percent of dose recovered unchanged in urine during the dosing interval(Aetau%) | up to 14 days | |
| Renal clearance (CLr) | up to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in serum uric acid level | up to 14 days | |
| Change from baseline in serum levels of xanthine and hypoxanthine | up to 14 days | |
| Urinary uric acid levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami Research Associates, Inc. | South Miami | Florida | 33143 | United States | ||
| MRA Clinical Research, LLC |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Placebo |
| Drug |
Placebo tablet once daily dosing for 14 days |
|
| PF-06743649 | Drug | To be decided dose, tablet once daily dosing for 14 days |
|
| Placebo | Drug | Placebo tablet once daily dosing for 14 days |
|
| PF-06743649 | Drug | To be decided dose, tablet once daily dosing for 14 days |
|
| Placebo | Drug | Placebo tablet once daily dosing for 14 days |
|
| PF-06743649 | Drug | To be decided dose, tablet once daily dosing for 14 days |
|
| Placebo | Drug | Placebo tablet once daily dosing for 14 days |
|
| PF-06743649 | Drug | To be decided dose, tablet once daily dosing for 14 days |
|
| Placebo | Drug | Placebo tablet once daily dosing for 14 days |
|
| up to 14 days |
| Urinary xanthine levels | up to 14 days |
| Urinary hypoxanthine levels | up to 14 days |
| South Miami |
| Florida |
| 33143 |
| United States |