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Study of a drug drug interaction between Paroxetine and PF-00299804.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DDI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Period 1 | Drug | Subjects will receive a single 45 mg dose of PF-00299804 on Day 1 of Period 1. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma AUCinf of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers | 8 weeks | |
| Plasma AUCt of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers | 8 weeks | |
| Plasma Cmax of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers | 8 weeks | |
| Plasma AUCinf of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers | 8 weeks | |
| Plasma AUCt of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers | 8 weeks | |
| Plasma Cmax of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma CL/F of PF-00299804 in EM without paroxetine. | 8 weeks | |
| Plasma Tmax of PF-00299804 in EM without paroxetine. | 8 weeks | |
| Plasma t1/2 of PF-00299804 in EM without paroxetine. |
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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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| Period 2 |
| Drug |
Subjects will receive a single 30 mg tablet of paroxetine once daily for 3 days (Days 1 to 3). Then, subjects will be co-administered a 45 mg single dose of PF-00299804 plus a single dose of 30 mg paroxetine on Day 4. Single 30 mg doses of paroxetine will be administered once daily for 6 days (Days 5-10). |
|
| 8 weeks |
| Plasma MRT of PF-00299804 in EM without paroxetine. | 8 weeks |
| Plasma CL/F of PF-00299804 in EM with paroxetine. | 8 weeks |
| Plasma Tmax of PF-00299804 in EM with paroxetine. | 8 weeks |
| Plasma t1/2 of PF-00299804 in EM with paroxetine. | 8 weeks |
| Plasma MRT of PF-00299804 in EM with paroxetine. | 8 weeks |
| Plasma AUCinf of PF-05199265 in EMs when given alone (if levels permit). | 8 weeks |
| Plasma AUCt of PF-05199265 in EMs when given alone (if levels permit). | 8 weeks |
| Plasma Cmax of PF-05199265 in EMs when given alone (if levels permit). | 8 weeks |
| Plasma Tmax of PF-05199265 in EMs when given in combination with paroxetine (if levels permit). | 8 weeks |
| Plasma t1/2 of PF-05199265 in EMs when given in combination with paroxetine (if levels permit). | 8 weeks |
| Overall safety profile as characterized by laboratory abnormalities, observed physical examination, vital signs, ECGs, and adverse event monitoring. | 8 weeks |