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

NCT01318031 | Completed Phase 1

• 1 other identifier: A7471021
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Keywords

DDI; Healthy Volunteers

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (14)

• 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

Study Arms (1)

DDI

EXPERIMENTAL

Drug: Period 1; Drug: Period 2

Interventions

Period 1 DRUG

Subjects will receive a single 45 mg dose of PF-00299804 on Day 1 of Period 1.

DDI

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).

DDI

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

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

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2011
• First Posted: March 18, 2011
• Study Start: March 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 22, 2012

Record last verified: 2012-06

Locations

US (1)