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

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

Official Title
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A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects

Conditions
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Generalized Anxiety Disease

Intervention / Treatment
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* Drug: Lithium
* Drug: PD 0332334
* Drug: Lithium
* Drug: PD 0332334


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1a<br>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<br>* 300 mg lithium, oral, once initially and then again at day 4 of PD 0332334 treatment<br>Drug: PD 0332334<br>* 225 mg q12h PD 0332334, oral, 9 days treatment<br>* Other names: imagabalin;|
| Experimental: Cohort 1b<br>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<br>* 300 mg lithium, oral, at day 4 of PD 0332334 treatment and after 7 day washout<br>Drug: PD 0332334<br>* 225 mg q12h PD 0332334, oral, 9 days treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| No Secondary Outcomes |  | No Secondary Outcomes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-drug interaction, lithium, PD 0332334, pharmacokinetics