Open-Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Tamoxifen When Coadministered To Healthy Post-Menopausal Female Subjects

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine SR on the pharmacokinetics of Tamoxifen and endoxifen when coadministered to healthy post-menopausal female subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Tamoxifen when coadministered to healthy post-menopausal female subjects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Pfizer
• Treatments: Desvenlafaxine Succinate; Tamoxifen

Criteria

Inclusion Criteria:

• Healthy post-menopausal female subjects, at least 45 years of age, with confirmed post-menopausal status

• Hysterectomized subjects

• Body Mass Index (BMI) less than or equal to 34.0 kg/m2

• Nonsmoker or smoker of fewer than 5 cigarettes per day as determined by history

• An informed consent document signed and dated by the subject

Exclusion Criteria:

• History of significant blood, kidney, endocrine, lung, gastrointestinal, heart, liver, psychiatric, neurologic, or allergic disease

• Presence or history of deep vein thrombosis or transient ischemic attack

• History of seizure disorder

• Presence or history of glaucoma or increased intraocular pressure

• Allergy to or unable to tolerate tamoxifen, desvenlafaxine, or venlafaxine

• History of substance abuse within 1 year of study

• A positive urine drug screen

• Treatment with an investigational drug within 30 days

• Consumption of grapefruit or grapefruit related citrus fruits

• 12 lead ECG demonstrating QTc >450 msec at screening

• Pregnant or nursing females

• Use of prescription or nonprescription drugs and dietary supplements

• History of sensitivity to heparin or heparin induced thrombocytopenia

• Severe acute or chronic medical or psychiatric condition or laboratory abnormality

• Use of CYP 2D6 inhibitors and CYP 3A4 inhibitors/inducers