Major Depressive DisorderPhase 4NCT00952653

Study Evaluating the Effect of Desvenlafaxine on the Pharmacokinetics of Midazolam

A Phase 4 study testing Desvenlafaxine Succinate Sustained Release and Midazolam in people with Major Depressive Disorder, run by Pfizer at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Major Depressive Disorder
What is being tested?: Desvenlafaxine Succinate Sustained Release and Midazolam
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 28 participants
Where: 1 siteUnited States
Study dates: Jun 2010to Aug 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Pfizer Investigational Site
New Haven, Connecticut, 06511

Other trials in United States

About this study

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

Conditions: Major Depressive Disorder
Being tested: Desvenlafaxine Succinate Sustained Release, Midazolam
Keywords: depression
Medical subject headings: Depressive Disorder, Major, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Desvenlafaxine Succinate Sustained ReleaseDrug
50 mg DVS SR tablet days 1-6, period 2 only.
MidazolamDrug
4 mg midazolam (2 mL midazolam syrup) day 1, period 1 and day 6, period 2.

Study groups in NCT00952653
Study group	Role	What they receive
DVS SR	Experimental	Not described Receives: Drug: Desvenlafaxine Succinate Sustained Release; Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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
Midazolam Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR
Cmax measured as nanograms per milliliters (ng/mL).
Measured: 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
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.
Measured: 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
1-Hydroxy-Midazolam (Analyte) Maximum Observed Plasma Concentration (Cmax) Following Midazolam Alone and When Coadministered With DVS SR
Measured: 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 (6)

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
Measured: 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
Midazolam Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR
Measured: 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
Midazolam Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR
Measured: 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
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
Measured: 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
1-Hydroxy-Midazolam (Analyte) Time to Cmax (Tmax) Following Midazolam Alone and When Coadministered With DVS SR
Measured: 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
1-Hydroxy-Midazolam (Analyte) Terminal Half-life (t 1/2) Following Midazolam Alone and When Coadministered With DVS SR
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2010Aug 2010

First posted6 Aug 2009 (estimated)
Study startJun 2010
Primary completionAug 2010
Study completionAug 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00952653
Sponsor's protocol ID: 3151A1-1205
Other IDs: B2061001
Status last verified: Aug 2011
First submitted: 3 Aug 2009
Last updated: 15 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00952653
Acronym / sponsor ID: 3151A1-1205
Conditions: Major Depressive Disorder
Keywords: depression
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Jun 2010
Primary completion: Aug 2010 (actual)
Study completion: Aug 2010 (actual)
First posted: 6 Aug 2009 (estimated)
Results: Posted 2 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DVS SR	Experimental	Drug: Desvenlafaxine Succinate Sustained Release, Drug: Midazolam

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Desvenlafaxine Succinate Sustained Release50 mg DVS SR tablet days 1-6, period 2 only.	Drug	DVS SR
Midazolam4 mg midazolam (2 mL midazolam syrup) day 1, period 1 and day 6, period 2.	Drug	DVS SR

Primary outcome

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
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
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
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

6 secondary outcomes

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
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
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
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
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
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

Results and safety

Results posted to the registry on 2 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DVS SR 50 mg, Midazolam 4 mg	28	28

Primary outcome: 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. Geometric mean (Standard Deviation). Unit: ng*hr/mL

Measure	Midazolam 4 mg (Period 1) n = 26	DVS SR 50 mg, Midazolam 4 mg (Period 2) n = 25
Value	54.69 (26.670)	39.45 (13.301)

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 78.33)

Population analysed: PK parameter analysis population: all enrolled and treated participants who had at least 1 of the PK parameters of primary interest in at least 1 treatment period. N=number of participants contributing to the mean.

Primary outcome: 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. Geometric mean (Standard Deviation). Unit: ng/mL

Measure	Midazolam 4 mg (Period 1) n = 26	DVS SR 50 mg, Midazolam 4 mg (Period 2) n = 26
Value	21.20 (7.1216)	18.24 (5.1116)

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 93.74)

Population analysed: PK parameter analysis population; N=number of participants contributing to the mean.

Primary outcome: 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. Geometric mean (Standard Deviation). Unit: ng*hr/mL

Measure	Midazolam 4 mg (Period 1) n = 26	DVS SR 50 mg, Midazolam 4 mg (Period 2) n = 26
Value	36.87 (28.230)	30.74 (14.649)

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 97.97)

Population analysed: PK parameter analysis population; N=number of participants contributing to the mean.

Primary outcome: 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. Geometric mean (Standard Deviation). Unit: ng/mL

Measure	Midazolam 4 mg (Period 1) n = 26	DVS SR 50 mg, Midazolam 4 mg (Period 2) n = 26
Value	14.93 (6.5282)	15.10 (6.2472)

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 110.11)

Population analysed: PK parameter analysis population; N=number of participants contributing to the mean.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Period 2 / Day 7 final visit (Adverse Events) or up to 28 days after last study treatment (Serious Adverse Events). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Midazolam 4 mg (Period 1)	0 of 28 (0%)	21 of 28 (75%)	Not reported
DVS SR 50 mg (Period 2 / Day 1 to Day 5)	0 of 28 (0%)	16 of 28 (57.1%)	Not reported
DVS SR 50 mg + Midazolam 4 mg (Period 2 / Day 6)	0 of 28 (0%)	24 of 28 (85.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Desvenlafaxine Succinate Sustained Release and Midazolam in people with Major Depressive Disorder, run by Pfizer at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00952653.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2011.