A Phase 1 Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects
NCT ID: NCT00820794
Last Updated: 2015-03-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2009-05-31
2009-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
NONE
Study Groups
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Cohort 1a
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.
Lithium
300 mg lithium, oral, once initially and then again at day 4 of PD 0332334 treatment
PD 0332334
225 mg q12h PD 0332334, oral, 9 days treatment
Cohort 1b
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.
Lithium
300 mg lithium, oral, at day 4 of PD 0332334 treatment and after 7 day washout
PD 0332334
225 mg q12h PD 0332334, oral, 9 days treatment
Interventions
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Lithium
300 mg lithium, oral, once initially and then again at day 4 of PD 0332334 treatment
PD 0332334
225 mg q12h PD 0332334, oral, 9 days treatment
Lithium
300 mg lithium, oral, at day 4 of PD 0332334 treatment and after 7 day washout
PD 0332334
225 mg q12h PD 0332334, oral, 9 days treatment
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age from 21 to 55 (inclusive)
* BMI ranges from 18 to 30 kg/m2
Exclusion Criteria
* Pregnant or nursing females
* Hypersensitivity (allergic) to lithium, Neurontin (gabapentin), or Lyrica (pregabalin)
21 Years
55 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer, Inc.
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A5361034
Identifier Type: -
Identifier Source: org_study_id
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