Generalized Anxiety DisorderPhase 1NCT00809536
Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time
A Phase 1 study testing Metformin and PD 0332334 in people with Generalized Anxiety Disorder, run by Pfizer at 1 site in Singapore.
Trial summary
1. To estimate the effects of multiple doses of PD 0332334 on the elimination of a single dose of metformin from the body 2. To estimate the effects of multiple doses of metformin on the elimination of a single dose of PD 0332334 from the body 3. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Metformin and PD 0332334
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2009to Feb 2009
- 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 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nonsmokers
- Male or female adults
Who cannot join
- Current or history of significant medical illness
- Smokers
- Illicit drug use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Pharmacokinetics Of PD 0332334 And Metformin When Administered Concurrently In Healthy Subjects
- To estimate the effects of multiple doses of PD 0332334 on the elimination of a single dose of metformin from the body
- To estimate the effects of multiple doses of metformin on the elimination of a single dose of PD 0332334 from the body
- To evaluate the safety and tolerability when PD 0332334 and metformin are administered at the same time.
Read the detailed description
Detailed Description:
Additional Study Purpose Details: To assess the pharmacokinetics of metformin and PD 0332334 with concurrent administration.
On February 18th 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Metformin, PD 0332334
- Keywords
- metformin, PD 0332334, organic cation transporter, OCT2, pharmacokinetics
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called imagabalin
225 mg q12, oral PD 0332334 immediate release formulation on Days 1 through 5; Single, oral, 500 mg dose of metformin immediate release
MetforminDrug
Single, oral, 500 mg of metformin immediate release
PD 0332334Drug
500 mg q12, oral metformin immediate release administered on Days 1 through Day 6 Single, oral, 300 mg dose of PD 0332334 immediate release formulation administered on Day 3
PD 0332334Drug
Single, oral, 300 mg dose of PD 0332334 immediate release formulation
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Other | This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults Receives: Drug: Metformin |
| Cohort 2 | Other | This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults Receives: Drug: PD 0332334 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf)
Measured: Days 1 through 7
Metformin and PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)
Measured: Days 1 through 7
Metformin and PD 0332334 half-life (t1/2)
Measured: Days 1 through 7
Metformin and PD 0332334 maximum plasma concentration
Measured: Days 1 through 7
Secondary outcomes (5)
Clinical safety laboratories
Measured: Days 1 through 7
Incidence, duration and severity of adverse events when study medications administered alone and concurrently
Measured: Days 1 through 7
Discontinuation due to adverse events when study medications administered alone and concurrently
Measured: Days 1 through 7
12-lead ECGs
Measured: Days 1 through 7
Vital signs
Measured: Days 1 through 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: Please Detailed Description for termination reason.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809536
- Sponsor's protocol ID
- A5361031
- Status last verified
- Feb 2010
- First submitted
- 15 Dec 2008
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Pharmacokinetics Of PD 0332334 And Metformin When Administered Concurrently In Healthy Subjects
- ClinicalTrials.gov ID
- NCT00809536
- Acronym / sponsor ID
- A5361031
- Conditions
- Generalized Anxiety Disorder
- Keywords
- metformin, PD 0332334, organic cation transporter, OCT2, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Please Detailed Description for termination reason.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 17 Dec 2008 (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 estimate the effects of multiple doses of PD 0332334 on the elimination of a single dose of metformin from the body
- To estimate the effects of multiple doses of metformin on the elimination of a single dose of PD 0332334 from the body
- To evaluate the safety and tolerability when PD 0332334 and metformin are administered at the same time.
Detailed description
Detailed Description:
Additional Study Purpose Details: To assess the pharmacokinetics of metformin and PD 0332334 with concurrent administration.
On February 18th 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Other | Drug: MetforminThis is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults |
| Cohort 2 | Other | Drug: PD 0332334This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Nonsmokers
- Male or female adults
Key exclusion criteria (3 listed)
- Current or history of significant medical illness
- Smokers
- Illicit drug use
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 |
|---|---|---|
| MetforminAlso: imagabalin225 mg q12, oral PD 0332334 immediate release formulation on Days 1 through 5; Single, oral, 500 mg dose of metformin immediate release | Drug | Cohort 1 |
| MetforminSingle, oral, 500 mg of metformin immediate release | Drug | Cohort 1 |
| PD 0332334500 mg q12, oral metformin immediate release administered on Days 1 through Day 6 Single, oral, 300 mg dose of PD 0332334 immediate release formulation administered on Day 3 | Drug | Cohort 2 |
| PD 0332334Single, oral, 300 mg dose of PD 0332334 immediate release formulation | Drug | Cohort 2 |
Primary outcome
Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf)
Time frame: Days 1 through 7
Metformin and PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)
Time frame: Days 1 through 7
Metformin and PD 0332334 half-life (t1/2)
Time frame: Days 1 through 7
Metformin and PD 0332334 maximum plasma concentration
Time frame: Days 1 through 7
5 secondary outcomes
Clinical safety laboratories
Time frame: Days 1 through 7
Incidence, duration and severity of adverse events when study medications administered alone and concurrently
Time frame: Days 1 through 7
Discontinuation due to adverse events when study medications administered alone and concurrently
Time frame: Days 1 through 7
12-lead ECGs
Time frame: Days 1 through 7
Vital signs
Time frame: Days 1 through 7
Results and safety
The study was stopped early (reason given: Please Detailed Description for termination reason.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2010.
- 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 Metformin and PD 0332334 in people with Generalized Anxiety Disorder, run by Pfizer at 1 site in Singapore.
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 2 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: stopped early, as of the sponsor's last update on 17 Feb 2010. 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 Singapore. 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 was stopped early (reason given: Please Detailed Description for termination reason.). Results are not available in the source record.
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?
Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf) (time frame: Days 1 through 7). 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?
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 17 Feb 2010.