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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

NCT ID: NCT01189500

Last Updated: 2011-11-07

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Tamoxifen and Desvenlafaxine SR

Group Type EXPERIMENTAL

Tamoxifen

Intervention Type DRUG

Period 1-Tamoxifen 40mg on study day 1.

Tamoxifen and Desvenlafaxine Succinate Sustained Release

Intervention Type DRUG

Period 2-Desvenlafaxine SR 100mg on days 1-28 with coadministration of Tamoxifen 40mg on day 7.

Interventions

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Tamoxifen

Period 1-Tamoxifen 40mg on study day 1.

Intervention Type DRUG

Tamoxifen and Desvenlafaxine Succinate Sustained Release

Period 2-Desvenlafaxine SR 100mg on days 1-28 with coadministration of Tamoxifen 40mg on day 7.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Countries

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United States

References

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Nichols AI, Lubaczewski S, Liang Y, Matschke K, Braley G, Ramey T. Open-label, 2-period sequential drug interaction study to evaluate the effect of a 100-mg dose of desvenlafaxine on the pharmacokinetics of tamoxifen when coadministered in healthy postmenopausal female subjects. Int J Clin Pharmacol Ther. 2014 Oct;52(10):830-41. doi: 10.5414/CP201958.

Reference Type DERIVED
PMID: 25138680 (View on PubMed)

Other Identifiers

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3151A1-1206

Identifier Type: -

Identifier Source: secondary_id

B2061027

Identifier Type: -

Identifier Source: org_study_id