Expired Study
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New Haven, Connecticut 06511


Purpose:

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.


Study summary:

Detailed Description: Additional Study Purpose Details: Evaluate the effects of multiple doses of cimetidine on the pharmacokinetics (e.g., elimination from the body) of a single dose of PD 0332334. On February 18th 2009, a decision to terminate further development for PD 0332334 was communicated to investigators in this study. The decision to terminate this study was not based on any safety concerns.


Criteria:

Inclusion Criteria: - healthy - male or female adults Exclusion Criteria: - Current or history of clinically significant medical illness - Smokers - Illicit drug use


Study is Available At:


Original ID:

A5361030


NCT ID:

NCT00800280


Secondary ID:


Study Acronym:


Brief Title:

Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body


Official Title:

A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of Steady-State Cimetidine On The Pharmacokinetics Of A Single Dose Of PD 0332334 In Healthy Subjects


Overall Status:

Terminated


Study Phase:

Phase 1


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

55 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Pfizer


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:

Please see Detailed Description for terminat


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

12


Enrollment Type:

Actual


Overall Contact Information

Official Name:Pfizer CT.gov Call Center
Study Director
Pfizer

Study Dates

Start Date:January 2009
Completion Date:February 2009
Completion Type:Actual
Primary Completion Date:February 2009
Primary Completion Type:Actual
Verification Date:February 2010
Last Changed Date:February 16, 2010
First Received Date:December 1, 2008

Study Outcomes

Outcome Type:Primary Outcome
Measure:PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf)
Time Frame:4 to 6 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)
Time Frame:4 to 6 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Half-life (t1/2) of PD 0332334
Time Frame:4 to 6 days
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Maximum plasma concentration (Cmax) of PD 0332334
Time Frame:4 to 6 days
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Evaluate the incidence, duration and severity of adverse events
Time Frame:4 to 6 days
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Evaluate the discontinuation due to adverse events
Time Frame:4 to 6 days
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Clinical safety labs
Time Frame:4 to 6 days
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:ECG
Time Frame:4 to 6 days
Safety Issues:True
Outcome Type:Secondary Outcome
Measure:Vital signs
Time Frame:4 to 6 days
Safety Issues:True

Study Interventions

Intervention Type:Drug
Name:PD 0332334
Description:Single 300 mg dose of PD 0332334 immediate release capsules administered orally
Arm Name:Single dose PD 0332334
Other Name:imagabalin
Intervention Type:Drug
Name:PD 0332334
Description:Single 300 mg dose of PD 0332334 immediate release capsules administered orally on Day 2.
Arm Name:Single dose PD 0332334 with steady-state cimetidin
Intervention Type:Drug
Name:cimetidine
Description:600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5.
Arm Name:Single dose PD 0332334 with steady-state cimetidin

Study Arms

Study Arm Type:Experimental
Arm Name:Single dose PD 0332334
Study Arm Type:Experimental
Arm Name:Single dose PD 0332334 with steady-state cimetidine

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Pfizer

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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