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The study will evaluate the hypothesis that at doses and plasma concentrations which affect pharmacodynamic markers of activity at the chemokine receptors, CCR2 and CCR5, the compound is safe and well tolerated. It will also evaluate the hypothesis that the pharmacokinetic profile is robust and consistent with a once or twice a day therapeutic administration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Cohort 1, 1mg | Experimental |
| |
| Cohort 1, 3mg | Experimental |
| |
| Cohort 1, 10mg | Experimental |
| |
| Cohort 2, 30mg | Experimental |
| |
| Cohort 2, 100mg | Experimental |
| |
| Cohort 2, 300mg | Experimental |
| |
| Cohort 3, 600mg | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04634817 Placebo | Drug | Oral solution, placebo, single dose |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and toleration: adverse events, supine and standing vital sign measurements, telemetry, 12-lead ECGs, blood and urine tests | 0-3 days | |
| Plasma pharmacokinetics: Cmax, Tmax, AUClast, AUCinf, AUC0-24, CL/F, Vz/F and T1/2 | 0-4 days | |
| Urinary pharmacokinetics: Aet (mount excreted in urine), Aet% and CLr | 0-2 days | |
| p-ERK inhibition in human monocytes | 0-3 days | |
| Change in circulating monocytes | 0-3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in plasma MCP-1 | 0-3 days | |
| MIP 1B stimulated CCR5 receptor internalization | 0-3 days | |
| MCP-1 stimulated CCR5 receptor internalization |
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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 |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | 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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| ID | Term |
|---|---|
| C000629947 | PF-04634817 |
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|
| Cohort 3, 900mg | Experimental |
|
| Cohort 3, up to 900mg (fed) | Experimental |
|
| Cohort 3, placebo (fed) | Placebo Comparator |
|
| PF-04634817 |
| Drug |
Oral solution, 1mg, single dose |
|
| PF-04634817 | Drug | Oral solution, 3mg, single dose |
|
| PF-04634817 | Drug | Oral solution, 10mg, single dose |
|
| PF-04634817 | Drug | Oral solution, 30mg, single dose |
|
| PF-04634817 | Drug | Oral solution, 100mg, single dose |
|
| PF-04634817 | Drug | Oral solution, 300mg, single dose |
|
| PF-04634817 | Drug | Oral solution, 600mg, single dose |
|
| PF-04634817 | Drug | Oral solution, 900mg, single dose |
|
| PF-04634817 | Drug | Oral solution, up to 900mg, single dose after food |
|
| PF-04634817 Placebo | Drug | Oral solution, placebo, single dose after food |
|
| 0-3 days |