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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00820794

Purpose

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	Intervention	Phase
Generalized Anxiety Disease	Drug: Lithium Drug: PD 0332334	Phase I

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

Resource links provided by NLM:

Drug Information available for: Lithium carbonate Lithium citrate

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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). [ Time Frame: 10 days ] [ Designated as safety issue: No ]
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. [ Time Frame: 10 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

No Secondary Outcomes [ Time Frame: No Secondary Outcomes ] [ Designated as safety issue: No ]

Estimated Enrollment:	12
Study Start Date:	May 2009
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Cohort 1a: Experimental 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
Cohort 1b: Experimental 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

Detailed Description:

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

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00820794

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5361034
Study First Received:	January 9, 2009
Last Updated:	February 26, 2009
ClinicalTrials.gov Identifier:	NCT00820794 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Drug-drug interaction, lithium, PD 0332334, pharmacokinetics

Additional relevant MeSH terms:

Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Lithium Carbonate
Central Nervous System Depressants
Enzyme Inhibitors

Antipsychotic Agents
Antimanic Agents
Pharmacologic Actions
Therapeutic Uses
Central Nervous System Agents
Lithium
Antidepressive Agents

ClinicalTrials.gov processed this record on November 27, 2009