Clinical trial NCT01318031: Study To Investigate The Potential Drug Drug Interaction (DDI) Between PF-00299804 And Paroxetine In Healthy Subjects
Official title: Phase 1 Single Dose Open Label Study To Investigate The Potential DDI Between PF-00299804 And Paroxetine In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: DDI
Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-03-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Study of a drug drug interaction between Paroxetine and PF-00299804.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females of non-childbearing potential between the ages of 18 and 55 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* An informed consent document signed and dated by the subject.
* Subjects who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Subjects must be extensive CYP2D6 metabolizers as determined by genotyping.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, dermatologic or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy).
* History of depression or other potential for increased suicidality with paroxetine.
* Family or personal medical history of prolonged QTc, congenital deafness or sudden death, or 12-lead ECG with QTc\>450 msec.
* A positive urine drug screen, use of tobacco or nicotine-containing products, or regular alcohol consumption exceeding 14 drinks/ week for females or 21 drinks/week for men within prior 6 months.
* Pregnant or nursing females and females of childbearing potential including those with tubal ligation. Women of 45 to 55 years of age who are postmenopausal must have confirmatory FSH test results at screening.
* Use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
* Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to dosing.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.

Primary outcomes:
measure: Plasma AUCinf of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
timeFrame: 8 weeks
measure: Plasma AUCt of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
timeFrame: 8 weeks
measure: Plasma Cmax of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers
timeFrame: 8 weeks
measure: Plasma AUCinf of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
timeFrame: 8 weeks
measure: Plasma AUCt of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
timeFrame: 8 weeks
measure: Plasma Cmax of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers
timeFrame: 8 weeks
Secondary outcomes:
measure: Plasma CL/F of PF-00299804 in EM without paroxetine.
timeFrame: 8 weeks
measure: Plasma Tmax of PF-00299804 in EM without paroxetine.
timeFrame: 8 weeks
measure: Plasma t1/2 of PF-00299804 in EM without paroxetine.
timeFrame: 8 weeks
measure: Plasma MRT of PF-00299804 in EM without paroxetine.
timeFrame: 8 weeks
measure: Plasma CL/F of PF-00299804 in EM with paroxetine.
timeFrame: 8 weeks
measure: Plasma Tmax of PF-00299804 in EM with paroxetine.
timeFrame: 8 weeks
measure: Plasma t1/2 of PF-00299804 in EM with paroxetine.
timeFrame: 8 weeks
measure: Plasma MRT of PF-00299804 in EM with paroxetine.
timeFrame: 8 weeks
measure: Plasma AUCinf of PF-05199265 in EMs when given alone (if levels permit).
timeFrame: 8 weeks
measure: Plasma AUCt of PF-05199265 in EMs when given alone (if levels permit).
timeFrame: 8 weeks
measure: Plasma Cmax of PF-05199265 in EMs when given alone (if levels permit).
timeFrame: 8 weeks
measure: Plasma Tmax of PF-05199265 in EMs when given in combination with paroxetine (if levels permit).
timeFrame: 8 weeks
measure: Plasma t1/2 of PF-05199265 in EMs when given in combination with paroxetine (if levels permit).
timeFrame: 8 weeks
measure: Overall safety profile as characterized by laboratory abnormalities, observed physical examination, vital signs, ECGs, and adverse event monitoring.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: