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

Pfizer

Status and phase

Completed

Phase 4

Conditions

Pharmacokinetics

Treatments

Drug: Tamoxifen

Drug: Tamoxifen and Desvenlafaxine Succinate Sustained Release

Study type

Interventional

Funder types

Industry

Identifiers

NCT01189500

3151A1-1206

B2061027

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

Female

Ages

45+ years old

Volunteers

Accepts Healthy Volunteers

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