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A Phase 1 Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects

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NCT00820794

Last updated on November 13, 2019
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Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Generalized Anxiety Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy males and/or females

- Age from 21 to 55 (inclusive)

- BMI ranges from 18 to 30 kg/m2

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Previous participation in a PD 332334 study

- Pregnant or nursing females

- Hypersensitivity (allergic) to lithium, Neurontin (gabapentin), or Lyrica (pregabalin)

NCT00820794
Pfizer
Withdrawn
A Phase 1 Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects

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Descriptive Information
Brief Title  ICMJE A Phase 1 Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects
Official Title  ICMJE A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects
Brief SummaryThe purpose of this study is to investigate if PD 0332334 affects the pharmacokinetics of lithium by co-administering both drugs to healthy adults.
Detailed DescriptionAdditional Study Purpose Details: To investigate potential drug-drug interaction between PD 0332334 and lithium
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Condition  ICMJE Generalized Anxiety Disease
Intervention  ICMJE
  • Drug: Lithium
    300 mg lithium, oral, once initially and then again at day 4 of PD 0332334 treatment
  • Drug: PD 0332334
    225 mg q12h PD 0332334, oral, 9 days treatment
    Other Name: imagabalin
  • Drug: Lithium
    300 mg lithium, oral, at day 4 of PD 0332334 treatment and after 7 day washout
  • Drug: PD 0332334
    225 mg q12h PD 0332334, oral, 9 days treatment
Study Arms  ICMJE
  • Experimental: 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.
    Interventions:
    • Drug: Lithium
    • Drug: PD 0332334
  • Experimental: 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.
    Interventions:
    • Drug: Lithium
    • Drug: PD 0332334
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: March 4, 2015)		0
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2009)		12
Estimated Study Completion Date  ICMJE June 2009
Estimated Primary Completion DateJune 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy males and/or females
  • Age from 21 to 55 (inclusive)
  • BMI ranges from 18 to 30 kg/m2

Exclusion Criteria:

  • Previous participation in a PD 332334 study
  • Pregnant or nursing females
  • Hypersensitivity (allergic) to lithium, Neurontin (gabapentin), or Lyrica (pregabalin)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location CountriesSingapore
 
Administrative Information
NCT Number  ICMJE NCT00820794
Other Study ID Numbers  ICMJE A5361034
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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