Investigation Of How PD 0332334 And Metformin Are Eliminated From The Body When They Are Administered At The Same Time

Phase 1

Terminated

• Conditions: Generalized Anxiety Disorder
• Interventions: Drug: PD 0332334; Drug: Metformin

• Registration Number: NCT00809536
• Lead Sponsor: Pfizer

Brief Summary

1. To estimate the effects of multiple doses of PD 0332334 on the elimination of a single dose of metformin from the body

2. To estimate the effects of multiple doses of metformin on the elimination of a single dose of PD 0332334 from the body

3. To evaluate the safety and tolerability when PD 0332334 and metformin are administered at the same time.

Detailed Description

Detailed Description:

Additional Study Purpose Details: To assess the pharmacokinetics of metformin and PD 0332334 with concurrent administration.

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.

Study Timeline

• Study First Submitted: 2008-12-15
• Study First Submitted QC: 2008-12-15
• Study First Posted: 2008-12-17
• Study Start: 2009-01
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-16
• Last Update Posted: 2010-02-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Nonsmokers
• Male or female adults

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 2	PD 0332334	This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults
Cohort 1	Metformin	This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults

Primary Outcome Measures

Name	Time	Method
Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf)	Days 1 through 7
Metformin and PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)	Days 1 through 7
Metformin and PD 0332334 half-life (t1/2)	Days 1 through 7
Metformin and PD 0332334 maximum plasma concentration	Days 1 through 7

Secondary Outcome Measures

Name	Time	Method
Clinical safety laboratories	Days 1 through 7
Incidence, duration and severity of adverse events when study medications administered alone and concurrently	Days 1 through 7
Discontinuation due to adverse events when study medications administered alone and concurrently	Days 1 through 7
12-lead ECGs	Days 1 through 7
Vital signs	Days 1 through 7

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore