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The most notable tolerability finding from these multiple dosing studies has been the occurrence of mild to moderate rash at doses of 450 mg BID and 600 mg BID. Based upon this finding, the current four week study is designed to examine whether a slow titration regimen up to a lower maintenance dose of 450 mg BID is able to reduce the incidence of rash.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A - active treatment | Experimental |
| |
| Arm B - placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-05089771 | Drug | titration from 150mg BID to 450mg BID |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Treatment-Related Adverse Events (AEs) or Serious Adverse Events (SAEs) | 28 days | |
| Area Under the Curve from Time Zero to end of dosing interval (AUCtau) | 12h | |
| Maximum Observed Plasma Concentration (Cmax) | 12h |
| Measure | Description | Time Frame |
|---|---|---|
| Minimum Observed Plasma Trough Concentration (Cmin) | 12h post dose |
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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 |
|---|---|
| C000618268 | PF-05089771 |
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| Placebo |
| Drug |
matched placebo |
|