Generalized Anxiety DiseasePhase 1NCT00820794
A Phase 1 Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects
A Phase 1 study testing Lithium and PD 0332334 in people with Generalized Anxiety Disease, run by Pfizer.
Trial summary
The purpose of this study is to investigate if PD 0332334 affects the pharmacokinetics of lithium by co-administering both drugs to healthy adults. 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 Disease
- What is being tested?
- Lithium and PD 0332334
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Jun 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
- Healthy males and/or females
- Age from 21 to 55 (inclusive)
- BMI ranges from 18 to 30 kg/m2
Who cannot join
- Previous participation in a PD 332334 study
- Pregnant or nursing females
- Hypersensitivity (allergic) to lithium, Neurontin (gabapentin), or Lyrica (pregabalin)
About this study
Official title: A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects
The purpose of this study is to investigate if PD 0332334 affects the pharmacokinetics of lithium by co-administering both drugs to healthy adults.
Read the detailed description
Additional Study Purpose Details: To investigate potential drug-drug interaction between PD 0332334 and lithium
- Conditions
- Generalized Anxiety Disease
- Being tested
- Lithium, PD 0332334
- Keywords
- Drug-drug interaction, lithium, PD 0332334, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithiumDrug
300 mg lithium, oral, once initially and then again at day 4 of PD 0332334 treatment
PD 0332334Drug
Also called imagabalin
225 mg q12h PD 0332334, oral, 9 days treatment
LithiumDrug
300 mg lithium, oral, at day 4 of PD 0332334 treatment and after 7 day washout
PD 0332334Drug
225 mg q12h PD 0332334, oral, 9 days treatment
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1a | Experimental | Subjects are treated with single dose lithium first. Then after at least 7 day washout, the subjects start PD 0332334 treatment from day 1 to day 9. At day 4 of PD 0332334 treatment, single dose lithium is given to subjects. Receives: Drug: Lithium; Drug: PD 0332334 |
| Cohort 1b | Experimental | Subjects are treated with PD 0332334 from day 1 to 9 and a single dose of lithium is given at day 4. After at least 7 day washout, the subjects are treated with single dose of lithium. Receives: Drug: Lithium; Drug: PD 0332334 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lithium pharmacokinetic endpoints: area under curve from 0 to infinity (AUCinf), area under curve from 0 to last quantifiable concentration (AUClast), half-life (T1/2), and maximum serum concentration (Cmax).
Measured: 10 days
The nature, incidence, duration, and severity of adverse events; discontinuation due to adverse events; clinical safety lab; 12-lead ECG; and vital signs will be monitored in this study.
Measured: 10 days
Secondary outcomes (1)
No Secondary Outcomes
Measured: No Secondary Outcomes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2009 (estimated)
- Study completionJun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DiseaseStudies 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
- 0 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
- NCT00820794
- Sponsor's protocol ID
- A5361034
- Status last verified
- Mar 2015
- First submitted
- 9 Jan 2009
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. 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 PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects
- ClinicalTrials.gov ID
- NCT00820794
- Acronym / sponsor ID
- A5361034
- Conditions
- Generalized Anxiety Disease
- Keywords
- Drug-drug interaction, lithium, PD 0332334, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 12 Jan 2009 (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 investigate if PD 0332334 affects the pharmacokinetics of lithium by co-administering both drugs to healthy adults.
Detailed description
Additional Study Purpose Details: To investigate potential drug-drug interaction between PD 0332334 and lithium
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1a | Experimental | Drug: Lithium, Drug: PD 0332334Subjects are treated with single dose lithium first. Then after at least 7 day washout, the subjects start PD 0332334 treatment from day 1 to day 9. At day 4 of PD 0332334 treatment, single dose lithium is given to subjects. |
| Cohort 1b | Experimental | Drug: Lithium, Drug: PD 0332334Subjects are treated with PD 0332334 from day 1 to 9 and a single dose of lithium is given at day 4. After at least 7 day washout, the subjects are treated with single dose of lithium. |
Who may qualify
- Ages
- 21 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males and/or females
- Age from 21 to 55 (inclusive)
- BMI ranges from 18 to 30 kg/m2
Key exclusion criteria (3 listed)
- Previous participation in a PD 332334 study
- Pregnant or nursing females
- Hypersensitivity (allergic) to lithium, Neurontin (gabapentin), or Lyrica (pregabalin)
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 |
|---|---|---|
| Lithium300 mg lithium, oral, once initially and then again at day 4 of PD 0332334 treatment | Drug | Cohort 1a |
| PD 0332334Also: imagabalin225 mg q12h PD 0332334, oral, 9 days treatment | Drug | Cohort 1a |
| Lithium300 mg lithium, oral, at day 4 of PD 0332334 treatment and after 7 day washout | Drug | Cohort 1b |
| PD 0332334225 mg q12h PD 0332334, oral, 9 days treatment | Drug | Cohort 1b |
Primary outcome
Lithium pharmacokinetic endpoints: area under curve from 0 to infinity (AUCinf), area under curve from 0 to last quantifiable concentration (AUClast), half-life (T1/2), and maximum serum concentration (Cmax).
Time frame: 10 days
The nature, incidence, duration, and severity of adverse events; discontinuation due to adverse events; clinical safety lab; 12-lead ECG; and vital signs will be monitored in this study.
Time frame: 10 days
1 secondary outcome
No Secondary Outcomes
Time frame: No Secondary Outcomes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
- 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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lithium and PD 0332334 in people with Generalized Anxiety Disease, run by Pfizer.
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: withdrawn, as of the sponsor's last update on 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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?
Lithium pharmacokinetic endpoints: area under curve from 0 to infinity (AUCinf), area under curve from 0 to last quantifiable concentration (AUClast), half-life (T1/2), and maximum serum concentration (Cmax). (time frame: 10 days). The study lists 2 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 5 Mar 2015.