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

Pfizer

Status and phase: Completed; Phase 4

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

Treatments: Drug: Aripiprazole + desvenlafaxine succinate sustained release; Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT01188668

B2061026

3151A1-1207

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Aripiprazole + Desvenlafaxine SR

Experimental group

Treatment:

Drug: Aripiprazole

Drug: Aripiprazole + desvenlafaxine succinate sustained release