Generalized Anxiety DisorderPhase 1NCT00800280
Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body
A Phase 1 study testing PD 0332334 and cimetidine in people with Generalized Anxiety Disorder, run by Pfizer at 1 site in United States.
Trial summary
The purpose of this study is to estimate the effects of multiple doses of cimetidine on the pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability of PD 0332334 when co-administered with cimetidine. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- PD 0332334 and cimetidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy
- male or female adults
Who cannot join
- Current or history of clinically significant medical illness
- Smokers
- Illicit drug use
Trial locations and contacts
1 site in 1 country.
United States1 site
Pfizer Investigational Site
New Haven, Connecticut, 06511
About this study
Official title: A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of Steady-State Cimetidine On The Pharmacokinetics Of A Single Dose Of PD 0332334 In Healthy Subjects
The purpose of this study is to estimate the effects of multiple doses of cimetidine on the pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability of PD 0332334 when co-administered with cimetidine.
Read the detailed description
Detailed Description:
Additional Study Purpose Details: Evaluate the effects of multiple doses of cimetidine on the pharmacokinetics (e.g., elimination from the body) of a single dose of PD 0332334.
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
- PD 0332334, cimetidine
- Keywords
- cimetidine, 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.
PD 0332334Drug
Also called imagabalin
Single 300 mg dose of PD 0332334 immediate release capsules administered orally
PD 0332334Drug
Single 300 mg dose of PD 0332334 immediate release capsules administered orally on Day 2.
cimetidineDrug
600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5.
| Study group | Role | What they receive |
|---|---|---|
| Single dose PD 0332334 | Experimental | Not described Receives: Drug: PD 0332334 |
| Single dose PD 0332334 with steady-state cimetidine | Experimental | Not described Receives: Drug: PD 0332334; Drug: cimetidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf)
Measured: 4 to 6 days
PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)
Measured: 4 to 6 days
Half-life (t1/2) of PD 0332334
Measured: 4 to 6 days
Maximum plasma concentration (Cmax) of PD 0332334
Measured: 4 to 6 days
Secondary outcomes (5)
Evaluate the incidence, duration and severity of adverse events
Measured: 4 to 6 days
Evaluate the discontinuation due to adverse events
Measured: 4 to 6 days
Clinical safety labs
Measured: 4 to 6 days
ECG
Measured: 4 to 6 days
Vital signs
Measured: 4 to 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionFeb 2009
- Study completionFeb 2009
Why it stopped: Please see 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
- 12 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
- NCT00800280
- Sponsor's protocol ID
- A5361030
- Status last verified
- Feb 2010
- First submitted
- 1 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 Effects Of Steady-State Cimetidine On The Pharmacokinetics Of A Single Dose Of PD 0332334 In Healthy Subjects
- ClinicalTrials.gov ID
- NCT00800280
- Acronym / sponsor ID
- A5361030
- Conditions
- Generalized Anxiety Disorder
- Keywords
- cimetidine, PD 0332334, organic cation transporter, OCT2, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Please see Detailed Description for termination reason.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 2 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.
The purpose of this study is to estimate the effects of multiple doses of cimetidine on the pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability of PD 0332334 when co-administered with cimetidine.
Detailed description
Detailed Description:
Additional Study Purpose Details: Evaluate the effects of multiple doses of cimetidine on the pharmacokinetics (e.g., elimination from the body) of a single dose of PD 0332334.
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 |
|---|---|---|
| Single dose PD 0332334 | Experimental | Drug: PD 0332334 |
| Single dose PD 0332334 with steady-state cimetidine | Experimental | Drug: PD 0332334, Drug: cimetidine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy
- male or female adults
Key exclusion criteria (3 listed)
- Current or history of clinically 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 |
|---|---|---|
| PD 0332334Also: imagabalinSingle 300 mg dose of PD 0332334 immediate release capsules administered orally | Drug | Single dose PD 0332334 |
| PD 0332334Single 300 mg dose of PD 0332334 immediate release capsules administered orally on Day 2. | Drug | Single dose PD 0332334 with steady-state cimetidine |
| cimetidine600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5. | Drug | Single dose PD 0332334 with steady-state cimetidine |
Primary outcome
PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf)
Time frame: 4 to 6 days
PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)
Time frame: 4 to 6 days
Half-life (t1/2) of PD 0332334
Time frame: 4 to 6 days
Maximum plasma concentration (Cmax) of PD 0332334
Time frame: 4 to 6 days
5 secondary outcomes
Evaluate the incidence, duration and severity of adverse events
Time frame: 4 to 6 days
Evaluate the discontinuation due to adverse events
Time frame: 4 to 6 days
Clinical safety labs
Time frame: 4 to 6 days
ECG
Time frame: 4 to 6 days
Vital signs
Time frame: 4 to 6 days
Results and safety
The study was stopped early (reason given: Please see 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 PD 0332334 and cimetidine in people with Generalized Anxiety 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 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 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 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 see 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?
PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf) (time frame: 4 to 6 days). 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.