NCT01188668

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2010

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
1 year until next milestone

Results Posted

Study results publicly available

October 17, 2011

Completed
Last Updated

November 7, 2011

Status Verified

November 1, 2011

Enrollment Period

2 months

First QC Date

August 24, 2010

Results QC Date

September 9, 2011

Last Update Submit

November 1, 2011

Conditions

PharmacokineticsCytochrome P-450 CYP2D6CYP3A4 Protein, Human

Keywords

Pharmacokineticsafety and tolerabilitygenetic testingCYP 2D6 and CYP 3A4

Outcome Measures

Primary Outcomes (1)

  • 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

    Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - ∞). It is obtained from AUC (0 - t) plus AUC (t - ∞); measured as nanograms multiplied by hours divided by milliliters (ng\*hr/mL).

    Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

Secondary Outcomes (13)

  • Aripiprazole Maximum Observed Plasma Concentration (Cmax) Following Aripiprazole Alone and When Coadministered With DVS SR

    Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

  • Aripiprazole Time for Cmax (Tmax) Following Aripiprazole Alone and When Coadministered With DVS SR

    Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

  • Aripiprazole Terminal Half-life (t 1/2) Following Aripiprazole Alone and When Coadministered With DVS SR

    Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

  • Aripiprazole Apparent Clearance (CL/F) Following Aripiprazole Alone and When Coadministered With DVS SR

    Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

  • Aripiprazole Apparent Volume of Distribution (Vz/F) Following Aripiprazole Alone and When Coadministered With DVS SR

    Period 1 / Day 1: 0, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48, 72, 120, 168, 216, 264, and 312 hours after dosing; Period 2 / Day 7: 0, 0.5, 1, 2, 3, 4, 6, 8, 12 and 16 hours after dosing; also 0 hour Period 2 / Day 8, 9, 10, 12, 14, 16, 18, and Day 20

  • +8 more secondary outcomes

Study Arms (1)

Aripiprazole + Desvenlafaxine SR

EXPERIMENTAL
Drug: AripiprazoleDrug: Aripiprazole + desvenlafaxine succinate sustained release

Interventions

AripiprazoleDRUG

Period 1-Aripiprazole 5mg on study day 1.

Also known as: DVS-233; Pristiq
Aripiprazole + Desvenlafaxine SR
Aripiprazole + desvenlafaxine succinate sustained releaseDRUG

Period 2-Desvenlafaxine SR 100mg on days 1-19 with coadministration of Aripiprazole 5mg on day 7.

Aripiprazole + Desvenlafaxine SR

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Pfizer Investigational Site

Miami, Florida, 33126, United States

Location

Pfizer Investigational Site

Miami, Florida, 33134, United States

Location

MeSH Terms

Interventions

AripiprazoleDesvenlafaxine Succinate

Intervention Hierarchy (Ancestors)

PiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCyclohexanolsHexanolsFatty AlcoholsAlcoholsOrganic ChemicalsCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsPhenolsBenzene DerivativesHydrocarbons, AromaticLipids

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2010

First Posted

August 25, 2010

Study Start

August 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

November 7, 2011

Results First Posted

October 17, 2011

Record last verified: 2011-11

Locations

US(2)