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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Drug Use Investigation for PAXIL Tablet

NCT01371435

Mental Disorders

COMPLETED

Major Depressive Disorder Study In Adults

NCT00049972

Major Depressive Disorder

COMPLETED PHASE4

A Placebo-Controlled Study to Investigate the Onset of Action of Paroxetine in Premenstrual Dysphoria

NCT00516113

Premenstrual Dysphoric Disorder Premenstrual Syndrome

COMPLETED PHASE4

A Study Of A New Medicine (GW597599B) For The Treatment Of Major Depressive Disorder

NCT00048204

Depressive Disorder, Major

COMPLETED PHASE2

An Eight-week Study of Saredutant and Paroxetine as Combination Treatment for Major Depressive Disorder

NCT00629551

Depressive Disorder, Major

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

DDI

Group Type EXPERIMENTAL

Period 1

Intervention Type DRUG

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

Period 2

Intervention Type 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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Period 1

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

Intervention Type 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).

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes