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The purpose of this study is to determine the safety, tolerability and pharmacokinetics of PF-04287881 after a single oral dose in healthy adult volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental |
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| Cohort 2 | Experimental |
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| Cohort 3 | Experimental |
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| Cohort 4 | Experimental |
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| Cohort 5 | Experimental |
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| Cohort 6 | Experimental |
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| Cohort 7 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-04287881 | Drug | 75 mg oral dose (prepared solution) given once |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of safety and tolerability of PF-04287881 after single oral dose. | Daily up to discharge, follow-up 7-10 days after dosing |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of PF-04287881 after a single oral dose. | Pre-dose; Multiple timepoints on Day 1; 24, 36 hours Day 2; Single sample on Days 3-7. |
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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 | 06511-5473 | 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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| Cohort 8 |
| Experimental |
Japanese volunteers, low dose previously tested (based on PK) |
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| Cohort 9 | Experimental | Japanese volunteers, intermediate dose previously tested (based on PK) |
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| Cohort 10 | Experimental | Japanese volunteers, high dose previously tested (based on safety) |
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| Placebo |
| Drug |
placebo to match 75 mg oral dose (prepared solution), given once |
|
| PF-04287881 | Drug | 150 mg oral dose (prepared solution) given once |
|
| Placebo | Drug | placebo to match 150 mg oral dose (prepared solution), given once |
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| PF-04287881 | Drug | 300 mg oral dose (prepared solution) given once |
|
| Placebo | Drug | placebo to match 300 mg oral dose (prepared solution), given once |
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| PF-04287881 | Drug | 750 mg oral dose (prepared solution) given once |
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| Placebo | Drug | placebo to match 750 mg oral dose (prepared solution), given once |
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| PF-04287881 | Drug | 1000 mg oral dose (prepared solution) given once |
|
| Placebo | Drug | placebo to match 1000 mg oral dose (prepared solution), given once |
|
| PF-04287881 | Drug | 1250 mg oral dose (prepared solution) given once |
|
| Placebo | Drug | placebo to match 1250 mg oral dose (prepared solution), given once |
|
| PF-04287881 | Drug | 1500 mg oral dose (prepared solution) given once |
|
| Placebo | Drug | placebo to match 1500 mg oral dose (prepared solution), given once |
|
| PF-04287881 | Drug | 300 mg oral dose (prepared solution) given once |
|
| Placebo | Drug | placebo to match 300 mg oral dose (prepared solution), given once |
|
| PF-04287881 | Drug | 750 mg oral dose (prepared solution) given once |
|
| Placebo | Drug | placebo to match 750 mg oral dose (prepared solution), given once |
|
| PF-04287881 | Drug | 1000 mg based on safety and PK from previous cohorts; oral dose (prepared solution) given once |
|
| Placebo | Drug | placebo to match 1000 mg oral dose (prepared solution), given once |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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