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

Sponsor
Pfizer (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT00820794
Collaborator
(none)
0
Enrollment
2
Arms
1
Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Detailed Description

Additional Study Purpose Details: To investigate potential drug-drug interaction between PD 0332334 and lithium

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Official Title:
A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects
Study Start Date :
May 1, 2009
Anticipated Primary Completion Date :
Jun 1, 2009
Anticipated Study Completion Date :
Jun 1, 2009

Arms and Interventions

Arm Intervention/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.

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 Names:
  • imagabalin

    		•
    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.

    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

    Outcome Measures

    Primary Outcome Measures

    1. 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). [10 days]

    2. 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. [10 days]

    Secondary Outcome Measures

    1. No Secondary Outcomes [No Secondary Outcomes]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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)

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Pfizer

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00820794
    Other Study ID Numbers:
    • A5361034
    First Posted:
    Jan 12, 2009
    Last Update Posted:
    Mar 5, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by , ,
    Drug-drug interaction, lithium, PD 0332334, pharmacokinetics
    Additional relevant MeSH terms:
    Lithium Carbonate

    Study Results

    No Results Posted as of Mar 5, 2015