You are here

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

Last updated on December 12, 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, Cytochrome P-450 CYP2D6, Human CYP3A4 Protein
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy male and/or female subjects between the ages of 18 and 55 years

- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)

- 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

- History of seizure disorder

- Presence or history of glaucoma or increased intraocular pressure

- Allergy to or unable to tolerate aripiprazole, 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

NCT01188668
Pfizer
Completed
Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Descriptive Information
Brief Title  ICMJE Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy 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 Aripiprazole When Coadministered In Healthy Subjects
Brief Summary The goal of this study is to evaluate the effect of multiple doses of Desvenlafaxine Sustained Release (SR) on the pharmacokinetics of Aripiprazole when coadministered to healthy adult subjects. This study will also evaluate the safety and tolerability of Desvenlafaxine SR and Aripiprazole when coadministered to healthy adult subjects.
Detailed Description Not 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
  • Cytochrome P-450 CYP2D6
  • CYP3A4 Protein, Human
Intervention  ICMJE
  • Drug: Aripiprazole
    Period 1-Aripiprazole 5mg on study day 1.
    Other Name: DVS-233; Pristiq
  • Drug: Aripiprazole + desvenlafaxine succinate sustained release
    Period 2-Desvenlafaxine SR 100mg on days 1-19 with coadministration of Aripiprazole 5mg on day 7.
Study Arms  ICMJE Experimental: Aripiprazole + Desvenlafaxine SR
Interventions:
  • Drug: Aripiprazole
  • Drug: Aripiprazole + desvenlafaxine succinate sustained release
Publications * Not Provided


*   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 24, 2010)
38
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date October 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 18 and 55 years
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)
  • 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
  • History of seizure disorder
  • Presence or history of glaucoma or increased intraocular pressure
  • Allergy to or unable to tolerate aripiprazole, 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (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 NCT01188668
Other Study ID Numbers  ICMJE B2061026
3151A1-1207
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2011

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now