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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01318031
• Other study ID #: A7471021
• Status: Completed
• Phase: Phase 1
• First received: February 17, 2011
• Last updated: June 21, 2012
• Start date: March 2011
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma AUCinf of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers		8 weeks	No
Primary	Plasma AUCt of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers		8 weeks	No
Primary	Plasma Cmax of PF-00299804 when given alone in healthy volunteers who are extensive CYP2D6 metabolizers		8 weeks	No
Primary	Plasma AUCinf of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers		8 weeks	No
Primary	Plasma AUCt of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers		8 weeks	No
Primary	Plasma Cmax of PF-00299804 when given in combination with paroxetine in healthy volunteers who are extensive CYP2D6 metabolizers		8 weeks	No
Secondary	Plasma CL/F of PF-00299804 in EM without paroxetine.		8 weeks	No
Secondary	Plasma Tmax of PF-00299804 in EM without paroxetine.		8 weeks	No
Secondary	Plasma t1/2 of PF-00299804 in EM without paroxetine.		8 weeks	No
Secondary	Plasma MRT of PF-00299804 in EM without paroxetine.		8 weeks	No
Secondary	Plasma CL/F of PF-00299804 in EM with paroxetine.		8 weeks	No
Secondary	Plasma Tmax of PF-00299804 in EM with paroxetine.		8 weeks	No
Secondary	Plasma t1/2 of PF-00299804 in EM with paroxetine.		8 weeks	No
Secondary	Plasma MRT of PF-00299804 in EM with paroxetine.		8 weeks	No
Secondary	Plasma AUCinf of PF-05199265 in EMs when given alone (if levels permit).		8 weeks	No
Secondary	Plasma AUCt of PF-05199265 in EMs when given alone (if levels permit).		8 weeks	No
Secondary	Plasma Cmax of PF-05199265 in EMs when given alone (if levels permit).		8 weeks	No
Secondary	Plasma Tmax of PF-05199265 in EMs when given in combination with paroxetine (if levels permit).		8 weeks	No
Secondary	Plasma t1/2 of PF-05199265 in EMs when given in combination with paroxetine (if levels permit).		8 weeks	No
Secondary	Overall safety profile as characterized by laboratory abnormalities, observed physical examination, vital signs, ECGs, and adverse event monitoring.		8 weeks	Yes

External Links

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