A Phase 1 Study To Estimate The Effects Of PD 0332334 On Lithium Pharmacokinetics In Healthy Subjects
Information source: Pfizer
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Generalized Anxiety Disease
Intervention: Lithium (Drug); PD 0332334 (Drug); Lithium (Drug); PD 0332334 (Drug)
Phase: Phase 1
Status: Not yet recruiting
Sponsored by: Pfizer Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer
Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
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.
Clinical Details
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 design: Other, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study
Primary outcome: 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).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.
Secondary outcome: No Secondary Outcomes
Detailed description:
Additional Study Purpose Details: To investigate potential drug-drug interaction between PD
0332334 and lithium
Eligibility
Minimum age: 21 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Pfizer CT.gov Call Center, Phone: 1-800-718-1021
Pfizer Investigational Site, Singapore 188770, Singapore
Additional Information
To obtain contact information for a study center near you, click here.
Starting date: March 2009
Ending date: April 2009
Last updated: February 6, 2009
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