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

Last updated on October 4, 2018

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Study Location
Contact
1-800-718-1021
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Withdrawn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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A Phase 1 Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects
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.
Additional Study Purpose Details: To investigate potential drug-drug interaction between PD 0332334 and lithium
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Generalized Anxiety Disease
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
June 2009
June 2009   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
21 Years to 55 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
Singapore
 
NCT00820794
A5361034
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2015

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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