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
Information source: Pfizer
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pharmacokinetics
Intervention: Tamoxifen (Drug); Tamoxifen and Desvenlafaxine Succinate Sustained Release (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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.
Clinical Details
Official title: An Open-Label, 2-Period Sequential Drug Interaction Study to Evaluate the Effect of a 100 Mg Dose of Desvenlafaxine SR on the Pharmacokinetics of Tamoxifen When Co-administered in Healthy Post-menopausal Female Subjects
Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Primary outcome: The pharmacokinetic (PK) endpoints will be tamoxifen and endoxifen AUCinf (as data permit) when co-administered with DVS SR.
Secondary outcome: Safety and tolerability assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments.The PK endpoints will be tamoxifen and endoxifen Cmax, tmax, t1/2, CL/F and Vz/F. The PK endpoints will be N-desmethyl-tamoxifen and 4 hydroxy-tamoxifen AUCinf (as data permit), Cmax, tmax, t1/2, CL/F and Vz/F. Plasma tamoxifen and metabolites (N desmethyl-tamoxifen, endoxifen and 4 hydroxy-tamoxifen) concentration data.
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
SeaView Research, Inc., Miami, Florida 33126, United States; Recruiting
Audrey E Martinez, MD, Phone: 305-644-9903
SeaView Research, Inc., Miami, Florida 33134, United States; Recruiting
Audrey E Martinez, MD, Phone: 305-644-9903
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: August 2010
Last updated: September 16, 2010
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