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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00820794
First received: January 9, 2009
Last updated: February 16, 2010
Last verified: February 2010
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
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:


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
Experimental: Cohort 1a
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
Other Name: imagabalin
Experimental: Cohort 1b
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00820794     History of Changes
Other Study ID Numbers: A5361034
Study First Received: January 9, 2009
Last Updated: February 16, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Drug-drug interaction, lithium, PD 0332334, pharmacokinetics

Additional relevant MeSH terms:
Lithium
Lithium Carbonate
Antidepressive Agents
Antimanic Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 20, 2014