Study of a drug drug interaction between Paroxetine and PF-00299804.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
14
Subjects will receive a single 45 mg dose of PF-00299804 on Day 1 of Period 1.
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).
Pfizer Investigational Site
New Haven, Connecticut, United States
Plasma AUCinf of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
Time frame: 8 weeks
Plasma AUCt of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
Time frame: 8 weeks
Plasma Cmax of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
Time frame: 8 weeks
Plasma AUCinf of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
Time frame: 8 weeks
Plasma AUCt of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
Time frame: 8 weeks
Plasma Cmax of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
Time frame: 8 weeks
Plasma CL/F of PF-00299804 in EM without paroxetine.
Time frame: 8 weeks
Plasma Tmax of PF-00299804 in EM without paroxetine.
Time frame: 8 weeks
Plasma t1/2 of PF-00299804 in EM without paroxetine.
Time frame: 8 weeks
Plasma MRT of PF-00299804 in EM without paroxetine.
Time frame: 8 weeks
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Plasma CL/F of PF-00299804 in EM with paroxetine.
Time frame: 8 weeks
Plasma Tmax of PF-00299804 in EM with paroxetine.
Time frame: 8 weeks
Plasma t1/2 of PF-00299804 in EM with paroxetine.
Time frame: 8 weeks
Plasma MRT of PF-00299804 in EM with paroxetine.
Time frame: 8 weeks
Plasma AUCinf of PF-05199265 in EMs when given alone (if levels permit).
Time frame: 8 weeks
Plasma AUCt of PF-05199265 in EMs when given alone (if levels permit).
Time frame: 8 weeks
Plasma Cmax of PF-05199265 in EMs when given alone (if levels permit).
Time frame: 8 weeks
Plasma Tmax of PF-05199265 in EMs when given in combination with paroxetine (if levels permit).
Time frame: 8 weeks
Plasma t1/2 of PF-05199265 in EMs when given in combination with paroxetine (if levels permit).
Time frame: 8 weeks
Overall safety profile as characterized by laboratory abnormalities, observed physical examination, vital signs, ECGs, and adverse event monitoring.
Time frame: 8 weeks