Major Depressive DisorderPhase 1NCT01443208
Pharmacokinetics and Safety of Desvenlafaxine in Korean Healthy Subjects Following Single and Multiple Oral Doses of Desvenlafaxine Succinate Sustained Release Tablet
A Phase 1 study testing desvenlafaxine in people with Major Depressive Disorder, run by Pfizer at 1 site in South Korea.
Trial summary
To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Dec 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy male and/or female subjects
- Between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
Who cannot join
- Elevated risk of suicide, in the opinion of the investigator or expert consultant
- Pregnant or nursing females
- Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy Subjects
To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.
- Conditions
- Major Depressive Disorder
- Being tested
- desvenlafaxine
- Keywords
- pharmacokinetics, safety, desvenlafaxine, Korean healthy subjects
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desvenlafaxineDrug
one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days
desvenlafaxineDrug
one 100 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days
desvenlafaxineDrug
two 100 mg desvenlafaxine succinate sustained-release tablets or matching placebo, single dose and once daily dose for 5 days
| Study group | Role | What they receive |
|---|---|---|
| 50 mg | Experimental | Not described Receives: Drug: desvenlafaxine |
| 100 mg | Experimental | Not described Receives: Drug: desvenlafaxine |
| 200 mg | Experimental | Not described Receives: Drug: desvenlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
For single dose: maximum concentration (Cmax)
Measured: day 1
For single dose: time to first occurence of Cmax (Tmax)
Measured: day 1
For single dose: area under curve (0-time for last quantifiable concentration) (AUClast)
Measured: day 1
For multiple dose: maximum concentration (Cmax)
Measured: day 8
For multiple dose: time to first occurence of Cmax (Tmax)
Measured: day 8
For multiple dose: trough concentration (Ctrough)
Measured: day 8
For multiple dose: area under curve (0-24hours) (AUC0-24)
Measured: day 8
Secondary outcomes (8)
For single dose if data permit: terminal elimination half life (t1/2)
Measured: day 1
For single dose if data permit: area under curve (0-infinity) (AUCinf)
Measured: day 1
For single dose if data permit: oral clearance (CL/F)
Measured: day 1
For single dose if data permit: apparent volume of distribution (Vz/F)
Measured: day 1
For multiple dose if data permit: accumulation factor (Rac)
Measured: day 8
For multiple dose if data permit: terminal elimination half life (t1/2)
Measured: day 8
For multiple dose if data permit: oral clearance (CL/F)
Measured: day 8
For multiple dose if data permit: apparent volume of distribution (Vz/F)
Measured: day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01443208
- Sponsor's protocol ID
- B2061137
- Status last verified
- Dec 2011
- First submitted
- 23 Sep 2011
- Last updated
- 2 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Subject- and Investigator-Blind, Placebo-Controlled, Parallel-Group, Single and Multiple-Dose Study of Desvenlafaxine in Korean Healthy Subjects
- ClinicalTrials.gov ID
- NCT01443208
- Acronym / sponsor ID
- B2061137
- Conditions
- Major Depressive Disorder
- Keywords
- pharmacokinetics, safety, desvenlafaxine, Korean healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 29 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the pharmacokinetics and safety of single dose and multiple doses of desvenlafaxine in Korean healthy subjects and compare to westerners.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 50 mg | Experimental | Drug: desvenlafaxine |
| 100 mg | Experimental | Drug: desvenlafaxine |
| 200 mg | Experimental | Drug: desvenlafaxine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male and/or female subjects
- Between the ages of 18 and 55 years, inclusive
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
Key exclusion criteria (3 listed)
- Elevated risk of suicide, in the opinion of the investigator or expert consultant
- Pregnant or nursing females
- Females of childbearing potential who are unwilling or unable to use an acceptable method of contraception
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 |
|---|---|---|
| desvenlafaxineone 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days | Drug | 50 mg |
| desvenlafaxineone 100 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days | Drug | 100 mg |
| desvenlafaxinetwo 100 mg desvenlafaxine succinate sustained-release tablets or matching placebo, single dose and once daily dose for 5 days | Drug | 200 mg |
Primary outcome
For single dose: maximum concentration (Cmax)
Time frame: day 1
For single dose: time to first occurence of Cmax (Tmax)
Time frame: day 1
For single dose: area under curve (0-time for last quantifiable concentration) (AUClast)
Time frame: day 1
For multiple dose: maximum concentration (Cmax)
Time frame: day 8
For multiple dose: time to first occurence of Cmax (Tmax)
Time frame: day 8
For multiple dose: trough concentration (Ctrough)
Time frame: day 8
For multiple dose: area under curve (0-24hours) (AUC0-24)
Time frame: day 8
8 secondary outcomes
For single dose if data permit: terminal elimination half life (t1/2)
Time frame: day 1
For single dose if data permit: area under curve (0-infinity) (AUCinf)
Time frame: day 1
For single dose if data permit: oral clearance (CL/F)
Time frame: day 1
For single dose if data permit: apparent volume of distribution (Vz/F)
Time frame: day 1
For multiple dose if data permit: accumulation factor (Rac)
Time frame: day 8
For multiple dose if data permit: terminal elimination half life (t1/2)
Time frame: day 8
For multiple dose if data permit: oral clearance (CL/F)
Time frame: day 8
For multiple dose if data permit: apparent volume of distribution (Vz/F)
Time frame: day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2012.
- 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 1 study testing desvenlafaxine in people with Major Depressive Disorder, run by Pfizer at 1 site in South Korea.
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 3 inclusion and 3 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 2 Jan 2012. 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 South Korea. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
For single dose: maximum concentration (Cmax) (time frame: day 1). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2012.