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Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Desvenlafaxine Succinate Sustained Release

Midazolam

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring depression

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Men or non-pregnant, non-lactating women, 18 to 55 years of age inclusive at screening.
Healthy as determined by the investigator on the basis of medical history, physical examination, clinical laboratory test results, vital signs, and 12-lead electrocardiogram (ECG).
Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history.
Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 Ilbs).

Exclusion Criteria:

Presence or history of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
Presence or history of glaucoma or intraocular pressure.
Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational product.
Allergy to midazolam, other benzodiazepine, desvenlafaxine, or venlafaxine.
Acute disease state (eg, nausea, vomiting, fever, or diarrhea) with 7 days before study day 1.
Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements. History of drug abuse within 1 year before study day 1.

Sites / Locations

Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DVS SR

Arm Description

Outcomes

Primary Outcome Measures

Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR

AUCinf measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).

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

Cmax measured as nanograms per milliliters (ng/mL).

1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR

1-Hydroxy-Midazolam is an analyte of Midazolam.

1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR

Secondary Outcome Measures

Midazolam Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR

Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR

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

1-Hydroxy-Midazolam (Analyte) Area Under the Plasma Concentration-time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) Following Midazolam Alone and When Coadministered With DVS SR

1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR

1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR

Full Information

NCT ID

NCT00952653

First Posted

August 3, 2009

Last Updated

August 9, 2011

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00952653

Brief Title

Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam

Official Title

An Open-Label, Two-Period, Sequential Drug Interaction Study to Evaluate the Effect of Multiple Doses of Desvenlafaxine Succinate Sustained Release (DVS SR) on the Pharmacokinetics of Midazolam When Coadministered in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

August 2011

Overall Recruitment Status

Completed

Study Start Date

June 2010 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The main purpose of this study is to evaluate the effect of desvenlafaxine administered as DVS SR on the pharmacokinetics of midazolam in healthy male and female subjects. The amount of drug in the body and the effect of the drug will also be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DVS SR

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Desvenlafaxine Succinate Sustained Release

Intervention Description

50 mg DVS SR tablet days 1-6, period 2 only.

Intervention Type

Drug

Intervention Name(s)

Midazolam

Intervention Description

4 mg midazolam (2 mL midazolam syrup) day 1, period 1 and day 6, period 2.

Primary Outcome Measure Information:

Title

Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR

Description

AUCinf measured as nanograms multiplied by hours divided by milliliters (ng*hr/mL).

Time Frame