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
Results First Received: July 6, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Major Depressive Disorder
Interventions: Drug: Desvenlafaxine Succinate Sustained Release
Drug: Midazolam

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
DVS SR 50 mg, Midazolam 4 mg Midazolam (MDZ) 4 milligram (mg) syrup (2 mg per milliliter [mg/mL]) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained-release formulation (DVS SR) 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.

Participant Flow for 2 periods

Period 1:   Period 1: MDZ Alone
    DVS SR 50 mg, Midazolam 4 mg  
STARTED     28  
COMPLETED     28  
NOT COMPLETED     0  

Period 2:   Period 2: Coadministration DVS SR, MDZ
    DVS SR 50 mg, Midazolam 4 mg  
STARTED     28  
COMPLETED     28  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
DVS SR 50 mg, Midazolam 4 mg Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1. DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.

Baseline Measures
    DVS SR 50 mg, Midazolam 4 mg  
Number of Participants  
[units: participants]
  28  
Age, Customized  
[units: participants]
 
18 to 25 years     2  
26 to 35 years     9  
36 to 45 years     13  
> 45 years     4  
Gender  
[units: participants]
 
Female     12  
Male     16  



  Outcome Measures
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1.  Primary:   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 ]

2.  Primary:   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 ]

3.  Primary:   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 ]

4.  Primary:   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 ]

5.  Secondary:   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 ]

6.  Secondary:   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 ]

7.  Secondary:   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 ]

8.  Secondary:   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 ]

9.  Secondary:   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 ]

10.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com


No publications provided


Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00952653     History of Changes
Other Study ID Numbers: 3151A1-1205, B2061001
Study First Received: August 3, 2009
Results First Received: July 6, 2011
Last Updated: August 9, 2011
Health Authority: United States: Food and Drug Administration