NCT00800280

Brief Summary

The purpose of this study is to estimate the effects of multiple doses of cimetidine on the pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability of PD 0332334 when co-administered with cimetidine.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

December 1, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 2, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 17, 2010

Status Verified

February 1, 2010

Enrollment Period

1 month

First QC Date

December 1, 2008

Last Update Submit

February 16, 2010

Conditions

Generalized Anxiety Disorder

Keywords

cimetidine, PD 0332334, organic cation transporter, OCT2, pharmacokinetics

Outcome Measures

Primary Outcomes (4)

  • PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf)

    4 to 6 days

  • PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)

    4 to 6 days

  • Half-life (t1/2) of PD 0332334

    4 to 6 days

  • Maximum plasma concentration (Cmax) of PD 0332334

    4 to 6 days

Secondary Outcomes (5)

  • Evaluate the incidence, duration and severity of adverse events

    4 to 6 days

  • Evaluate the discontinuation due to adverse events

    4 to 6 days

  • Clinical safety labs

    4 to 6 days

  • ECG

    4 to 6 days

  • Vital signs

    4 to 6 days

Study Arms (2)

Single dose PD 0332334

EXPERIMENTAL
Drug: PD 0332334

Single dose PD 0332334 with steady-state cimetidine

EXPERIMENTAL
Drug: PD 0332334Drug: cimetidine

Interventions

PD 0332334DRUG

Single 300 mg dose of PD 0332334 immediate release capsules administered orally

Also known as: imagabalin
Single dose PD 0332334
cimetidineDRUG

600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5.

Single dose PD 0332334 with steady-state cimetidine

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy
  • male or female adults

You may not qualify if:

  • Current or history of clinically significant medical illness
  • Smokers
  • Illicit drug use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511, United States

Location

Related Links

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

imagabalinCimetidine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

GuanidinesAmidinesOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 1, 2008

First Posted

December 2, 2008

Study Start

January 1, 2009

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

February 17, 2010

Record last verified: 2010-02

Locations

US(1)