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

Phase 1

Withdrawn

• Conditions: Generalized Anxiety Disease
• Interventions: Drug: Lithium; Drug: PD 0332334

• Registration Number: NCT00820794
• Lead Sponsor: Pfizer

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2009-01-09
• Study First Submitted QC: 2009-01-09
• Study First Posted: 2009-01-12
• Study Start: 2009-05
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-04
• Last Update Posted: 2015-03-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 1b	PD 0332334	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.
Cohort 1a	Lithium	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.
Cohort 1b	Lithium	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.
Cohort 1a	PD 0332334	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.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
No Secondary Outcomes	No Secondary Outcomes