NCT00820794

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2009

Shorter than P25 for phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

1 month

First QC Date

January 9, 2009

Last Update Submit

March 4, 2015

Conditions

Generalized Anxiety Disease

Keywords

Drug-drug interaction, lithium, PD 0332334, pharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Secondary Outcomes (1)

  • No Secondary Outcomes

    No Secondary Outcomes

Study Arms (2)

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: LithiumDrug: PD 0332334

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: LithiumDrug: PD 0332334

Interventions

LithiumDRUG

300 mg lithium, oral, once initially and then again at day 4 of PD 0332334 treatment

Cohort 1a
PD 0332334DRUG

225 mg q12h PD 0332334, oral, 9 days treatment

Also known as: imagabalin
Cohort 1a

Eligibility Criteria

Age21 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy males and/or females
  • Age from 21 to 55 (inclusive)
  • BMI ranges from 18 to 30 kg/m2

You may not qualify if:

  • Previous participation in a PD 332334 study
  • Pregnant or nursing females
  • Hypersensitivity (allergic) to lithium, Neurontin (gabapentin), or Lyrica (pregabalin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Interventions

Lithiumimagabalin

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 9, 2009

First Posted

January 12, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

March 5, 2015

Record last verified: 2015-03