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Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00952653
First received: August 3, 2009
Last updated: August 9, 2011
Last verified: August 2011

August 3, 2009
August 9, 2011
June 2010
August 2010   (final data collection date for primary outcome measure)
  • 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 [ Time Frame: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing ] [ Designated as safety issue: No ]
    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 [ Time Frame: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing ] [ Designated as safety issue: No ]
    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 [ Time Frame: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing ] [ Designated as safety issue: No ]
    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 [ Time Frame: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing ] [ Designated as safety issue: No ]
Pharmacokinetic parameters including plasma concentration, Cmax, and AUC. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00952653 on ClinicalTrials.gov Archive Site
  • 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 [ Time Frame: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing ] [ Designated as safety issue: No ]
  • Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR [ Time Frame: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing ] [ Designated as safety issue: No ]
  • Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR [ Time Frame: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing ] [ Designated as safety issue: No ]
  • 1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR [ Time Frame: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing ] [ Designated as safety issue: No ]
  • 1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR [ Time Frame: Period 1 / Day 1 and Period 2 / Day 6: 0, 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, and 24 hours following dosing ] [ Designated as safety issue: No ]
Safety assessments as measured by evaluating any reported adverse events, scheduled physical examinations, vital signs assessments, ECGs, and clinical laboratory results. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam
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

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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Desvenlafaxine Succinate Sustained Release
    50 mg DVS SR tablet days 1-6, period 2 only.
  • Drug: Midazolam
    4 mg midazolam (2 mL midazolam syrup) day 1, period 1 and day 6, period 2.
Experimental: DVS SR
Interventions:
  • Drug: Desvenlafaxine Succinate Sustained Release
  • Drug: Midazolam
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
August 2010
August 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00952653
3151A1-1205, B2061001
No
Director, Clinical Trial Disclosure Group, Pfizer, Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP