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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01318031
First received: February 17, 2011
Last updated: June 21, 2012
Last verified: June 2012
  Purpose

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


Condition Intervention Phase
Healthy Volunteers
Drug: Period 1
Drug: Period 2
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Phase 1 Single Dose Open Label Study To Investigate The Potential DDI Between PF-00299804 And Paroxetine In Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Plasma AUCinf of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma AUCt of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma Cmax of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma AUCinf of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma AUCt of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma Cmax of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Plasma CL/F of PF-00299804 in EM without paroxetine. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma Tmax of PF-00299804 in EM without paroxetine. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma t1/2 of PF-00299804 in EM without paroxetine. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma MRT of PF-00299804 in EM without paroxetine. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma CL/F of PF-00299804 in EM with paroxetine. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma Tmax of PF-00299804 in EM with paroxetine. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma t1/2 of PF-00299804 in EM with paroxetine. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma MRT of PF-00299804 in EM with paroxetine. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma AUCinf of PF-05199265 in EMs when given alone (if levels permit). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma AUCt of PF-05199265 in EMs when given alone (if levels permit). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma Cmax of PF-05199265 in EMs when given alone (if levels permit). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma Tmax of PF-05199265 in EMs when given in combination with paroxetine (if levels permit). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Plasma t1/2 of PF-05199265 in EMs when given in combination with paroxetine (if levels permit). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Overall safety profile as characterized by laboratory abnormalities, observed physical examination, vital signs, ECGs, and adverse event monitoring. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 14
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01318031

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01318031     History of Changes
Other Study ID Numbers: A7471021
Study First Received: February 17, 2011
Last Updated: June 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Pfizer:
DDI
Healthy Volunteers

Additional relevant MeSH terms:
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 18, 2014