Study To Investigate The Potential Drug Drug Interaction (DDI) Between PF-00299804 And Paroxetine In Healthy Subjects

Phase 1 Single Dose Open Label Study To Investigate The Potential DDI Between PF-00299804 And Paroxetine In Healthy Subjects

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Period 1; Drug: Period 2

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: DDI

Drug: Period 1; Subjects will receive a single 45 mg dose of PF-00299804 on Day 1 of Period 1.; Drug: Period 2; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: February 17, 2011
• First Submitted That Met QC Criteria: March 16, 2011
• First Posted (Estimate): March 18, 2011

Study Record Updates

• Last Update Posted (Estimate): June 22, 2012
• Last Update Submitted That Met QC Criteria: June 21, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Healthy Volunteers; DDI
• Other Study ID Numbers: A7471021