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

Completed · Phase 4

Conditions studied: Pharmacokinetics, Cytochrome P-450 CYP2D6, CYP3A4 Protein, Human

In brief

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.

Key facts

Study ID

NCT01188668

Run by

Pfizer

People needed

38

Starts

2010-08-01

Expected to finish

2010-10-01

Last updated by the study team

2011-11-07

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States

Full record on ClinicalTrials.gov

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