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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
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Status: Withdrawn

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

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

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: May 2009
Last updated: March 4, 2015

Page last updated: August 23, 2015

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