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The purpose of this study in healthy 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. The effect of food on PK of PF-06743649 will also be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1-PF-06743649 or placebo | Experimental | Subjects will be randomized to receive PF-06743649 or placebo as 2 single doses in periods 1 and 2 either in the fed or fasted state followed by once daily dosing for 14 days in period 3 |
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| Cohort 2-PF-06743649 or placebo | Experimental |
| |
| Cohort 3-PF-06743649 or placebo | Experimental |
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| Cohort 4-PF-06743649 or placebo | Experimental |
| |
| Cohort 5-PF-06743649 or placebo | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06743649 | Drug | 40 mg tablet one time once with a meal and once without a meal, followed by 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 |
|---|---|---|---|---|---|---|
| New Haven Clinical Research Unit | New Haven | Connecticut | 06511 | United States |
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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 one time once with a meal and once without a meal, followed by once daily dosing for 14 days |
|
| PF-06743649 | Drug | To be decided dose, tablet once daily dosing for 14 days |
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| Placebo | Drug | Placebo tablet once daily dosing for 14 days |
|
| PF-06743649 | Drug | To be decided dose, tablet, one time once with a meal and once without a meal, followed by once daily dosing for 14 days |
|
| Placebo | Drug | Placebo tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days |
|
| PF-06743649 | Drug | To be decided dose, tablet, one time without a meal, followed by once daily dosing for 14 days |
|
| Placebo | Drug | Placebo tablet one time once without a meal, followed by once daily dosing for 14 days |
|
| PF-06743649 | Drug | Tablet, to be decided dose, once daily, 14 days |
|
| Placebo | Drug | Tablet, once daily, 14 days |
|
| up to 14 days |
| Urinary xanthine levels | up to 14 days |
| Urinary hypoxanthine levels | up to 14 days |