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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

Last updated on December 5, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Miami, Florida, 33126 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pharmacokinetics
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
45 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01189500
Pfizer
Completed
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

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Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief SummaryThe 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 DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Pharmacokinetics
Intervention  ICMJE
  • Drug: Tamoxifen
    Period 1-Tamoxifen 40mg on study day 1.
  • Drug: Tamoxifen and Desvenlafaxine Succinate Sustained Release
    Period 2-Desvenlafaxine SR 100mg on days 1-28 with coadministration of Tamoxifen 40mg on day 7.
Study Arms  ICMJE Experimental: Tamoxifen and Desvenlafaxine SR
Interventions:
  • Drug: Tamoxifen
  • Drug: Tamoxifen and Desvenlafaxine Succinate Sustained Release
Publications *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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 25, 2010)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion DateOctober 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01189500
Other Study ID Numbers  ICMJE B2061027
3151A1-1206
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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