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CompletedNCT00952653Updated Aug 15, 2011Results posted

Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam

A Phase 4 interventional study of Desvenlafaxine Succinate Sustained Release and Midazolam in Major Depressive Disorder, sponsored by Pfizer. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-08-15.

Sponsored by Pfizer · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
28
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Major Depressive Disorder

Keywords

  • depression
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 28 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.

Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    DVS SR

    Drug: Desvenlafaxine Succinate Sustained Release · Drug: Midazolam

Interventions

  • DrugDesvenlafaxine Succinate Sustained Release

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

  • DrugMidazolam

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

06

What researchers measure

Primary outcomes

  1. 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).

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

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

    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. 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.

    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. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

07

Results

Posted Aug 2, 2011

Participant flow

Period 1: MDZ Alone
Participant flow — Period 1: MDZ Alone
MilestoneDVS SR 50 mg, Midazolam 4 mg
Started28
Completed28
Not completed0
Period 2: Coadministration DVS SR, MDZ
Participant flow — Period 2: Coadministration DVS SR, MDZ
MilestoneDVS SR 50 mg, Midazolam 4 mg
Started28
Completed28
Not completed0

Outcome measures

PrimaryMidazolam 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).

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
Reported as:
Geometric mean · ng*hr/mL
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
ng*hr/mLMidazolam 4 mg (Period 1)DVS SR 50 mg, Midazolam 4 mg (Period 2)
Midazolam Area Under the Plasma Concentration-time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) Following Midazolam Alone and When Coadministered With DVS SR54.69 ± 26.67039.45 ± 13.301
Statistical analysis
  • Midazolam 4 mg (Period 1) vs DVS SR 50 mg, Midazolam 4 mg (Period 2) · Ratio of adjusted geometric means: 71.40 · 90% CI 65.08 to 78.33Values have been back-transformed from the log scale.
PrimaryMidazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR

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

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
Reported as:
Geometric mean · ng/mL
Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR
ng/mLMidazolam 4 mg (Period 1)DVS SR 50 mg, Midazolam 4 mg (Period 2)
Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR21.20 ± 7.121618.24 ± 5.1116
Statistical analysis
  • Midazolam 4 mg (Period 1) vs DVS SR 50 mg, Midazolam 4 mg (Period 2) · Ratio of adjusted geometric means: 86.08 · 90% CI 79.04 to 93.74Values have been back-transformed from the log scale.
Primary1-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.

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
Reported as:
Geometric mean · ng*hr/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
ng*hr/mLMidazolam 4 mg (Period 1)DVS SR 50 mg, Midazolam 4 mg (Period 2)
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 SR36.87 ± 28.23030.74 ± 14.649
Statistical analysis
  • Midazolam 4 mg (Period 1) vs DVS SR 50 mg, Midazolam 4 mg (Period 2) · Ratio of adjusted geometric means: 92.55 · 90% CI 87.43 to 97.97Values have been back-transformed from the log scale.
Primary1-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
Reported as:
Geometric mean · ng/mL
1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR
ng/mLMidazolam 4 mg (Period 1)DVS SR 50 mg, Midazolam 4 mg (Period 2)
1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR14.93 ± 6.528215.10 ± 6.2472
Statistical analysis
  • Midazolam 4 mg (Period 1) vs DVS SR 50 mg, Midazolam 4 mg (Period 2) · Ratio of adjusted geometric means: 101.17 · 90% CI 92.96 to 110.11Values have been back-transformed from the log scale.
SecondaryMidazolam 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
Reported as:
Geometric mean · ng*hr/mL
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
ng*hr/mLMidazolam 4 mg (Period 1)DVS SR 50 mg, Midazolam 4 mg (Period 2)
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 SR52.85 ± 23.98038.11 ± 12.522
Statistical analysis
  • Midazolam 4 mg (Period 1) vs DVS SR 50 mg, Midazolam 4 mg (Period 2) · Ratio of adjusted geometric means: 72.10 · 90% CI 66.04 to 78.72Values have been back-transformed from the log scale.
SecondaryMidazolam 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
Reported as:
Median · hr
Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR
hrMidazolam 4 mg (Period 1)DVS SR 50 mg, Midazolam 4 mg (Period 2)
Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR0.517 (0.250 to 1.50)0.500 (0.250 to 1.02)
SecondaryMidazolam 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
Reported as:
Mean · hr
Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR
hrMidazolam 4 mg (Period 1)DVS SR 50 mg, Midazolam 4 mg (Period 2)
Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR5.320 ± 1.59484.648 ± 1.7436
Secondary1-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
Reported as:
Geometric mean · ng*hr/mL
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
ng*hr/mLMidazolam 4 mg (Period 1)DVS SR 50 mg, Midazolam 4 mg (Period 2)
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 SR37.09 ± 25.37132.42 ± 14.881
Statistical analysis
  • Midazolam 4 mg (Period 1) vs DVS SR 50 mg, Midazolam 4 mg (Period 2) · Ratio of adjusted geometric means: 87.39 · 90% CI 80.42 to 94.96Values have been back-transformed from the log scale.
Secondary1-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
Reported as:
Median · hr
1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR
hrMidazolam 4 mg (Period 1)DVS SR 50 mg, Midazolam 4 mg (Period 2)
1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR1.00 (0.250 to 1.50)0.500 (0.250 to 1.02)
Secondary1-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
Reported as:
Mean · hr
1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR
hrMidazolam 4 mg (Period 1)DVS SR 50 mg, Midazolam 4 mg (Period 2)
1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR5.396 ± 2.06384.616 ± 1.7976

Adverse events

Collected over Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Midazolam 4 mg (Period 1)—0/28 (0%)21/28 (75%)
DVS SR 50 mg (Period 2 / Day 1 to Day 5)—0/28 (0%)16/28 (57.1%)
DVS SR 50 mg + Midazolam 4 mg (Period 2 / Day 6)—0/28 (0%)24/28 (85.7%)
Most frequent other events
Showing 10 of 28
Most frequent other events
EventMidazolam 4 mg (Period 1)DVS SR 50 mg (Period 2 / Day 1 to Day 5)DVS SR 50 mg + Midazolam 4 mg (Period 2 / Day 6)
SomnolenceNervous system disorders20/280/2820/28
HeadacheNervous system disorders0/286/281/28
Abdominal painGastrointestinal disorders1/284/280/28
FatigueGeneral disorders0/283/284/28
NauseaGastrointestinal disorders0/283/280/28
InsomniaPsychiatric disorders0/283/281/28
DiarrhoeaGastrointestinal disorders0/282/280/28
Feeling abnormalGeneral disorders0/282/280/28
Decreased appetiteMetabolism and nutrition disorders0/282/280/28
Abdominal discomfortGastrointestinal disorders0/281/280/28

Baseline characteristics

Age, Customized
Age, Customized(participants)DVS SR 50 mg, Midazolam 4 mg
18 to 25 years2
26 to 35 years9
36 to 45 years13
> 45 years4
Sex: Female, Male
Sex: Female, Male(Participants)DVS SR 50 mg, Midazolam 4 mg
Female12
Male16
08

Study locations

1 site
  • Pfizer Investigational Site
    New Haven, Connecticut 06511, United States
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00952653
Lead sponsor
Pfizer
First posted
Aug 6, 2009
Start date
Jun 2010
Primary completion
Aug 2010
Completion
Aug 2010
Results posted
Aug 2, 2011
Last update
Aug 15, 2011

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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