Phase 4
Completed N=38
Open Label Drug Interaction Study Evaluating Desvenlafaxine Succinate Sustained Release (DVS SR) 100mg On The Pharmacokinetics Of Aripiprazole When Coadministered To Healthy Subjects
Pharmacokinetics · Cytochrome P-450 CYP2D6 · CYP3A4 Protein, Human
Source: ClinicalTrials.gov NCT01188668 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Oct 2011
Primary outcomePrimary: Aripiprazole Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR — 1494; 1604 ng*hr/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Aripiprazole Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR |
1494; 1604 | — |
| SECONDARY Aripiprazole Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR |
24.66; 24.69 | — |
| SECONDARY Aripiprazole Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR |
3.00; 4.00 | — |
| SECONDARY Aripiprazole Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR |
85.17; 84.18 | — |
| SECONDARY Aripiprazole Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR |
55.76; 51.92 | — |
| SECONDARY Aripiprazole Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR |
397.3; 368.1 | — |
| SECONDARY Dehydro-aripiprazole (Metabolite) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Aripiprazole Alone and When Coadministered With DVS SR |
695.9; 685.8 | — |
| SECONDARY Dehydro-aripiprazole (Metabolite) Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR |
3.007; 3.185 | — |
| SECONDARY Dehydro-aripiprazole (Metabolite) Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR |
59.9; 71.9 | — |
| SECONDARY Dehydro-aripiprazole (Metabolite) Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR |
97.78; 94.27 | — |
| SECONDARY Dehydro-aripiprazole (Metabolite) Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR |
— | — |
| SECONDARY Dehydro-aripiprazole (Metabolite) Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR |
— | — |
| SECONDARY Plasma Aripiprazole Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg + Aripiprazole 5 mg |
NA; 0.1290; 0.4800; 1.220; 10.69; 9.545 | — |
| SECONDARY Plasma Dehydro-aripiprazole (Metabolite) Concentration Versus Time Summary: Aripiprazole 5mg, DVS SR 100 mg, Aripiprazole 5 mg |
NA; 0.1640; 0.0000; 0.2120; 0.2740; 0.5965 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01188668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.