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

Generalized Anxiety Disorder Clinical Trial

Official title:

A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Pharmacokinetics Of PD 0332334 And Metformin When Administered Concurrently In Healthy Subjects

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00809536
• Other study ID #: A5361031
• Status: Terminated
• Phase: Phase 1
• First received: December 15, 2008
• Last updated: February 16, 2010
• Start date: January 2009
• Est. completion date: February 2009

Study information

• Verified date: February 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

Inclusion Criteria:

• Nonsmokers

• Male or female adults

Exclusion Criteria:

• Current or history of significant medical illness

• Smokers

• Illicit drug use

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• Metformin
225 mg q12, oral PD 0332334 immediate release formulation on Days 1 through 5; Single, oral, 500 mg dose of metformin immediate release
• Metformin
Single, oral, 500 mg of metformin immediate release
• PD 0332334
500 mg q12, oral metformin immediate release administered on Days 1 through Day 6 Single, oral, 300 mg dose of PD 0332334 immediate release formulation administered on Day 3
• PD 0332334
Single, oral, 300 mg dose of PD 0332334 immediate release formulation

Locations

Country	Name	City	State
Singapore	Pfizer Investigational Site	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf)		Days 1 through 7	No
Primary	Metformin and PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)		Days 1 through 7	No
Primary	Metformin and PD 0332334 half-life (t1/2)		Days 1 through 7	No
Primary	Metformin and PD 0332334 maximum plasma concentration		Days 1 through 7	No
Secondary	Clinical safety laboratories		Days 1 through 7	Yes
Secondary	Incidence, duration and severity of adverse events when study medications administered alone and concurrently		Days 1 through 7	Yes
Secondary	Discontinuation due to adverse events when study medications administered alone and concurrently		Days 1 through 7	Yes
Secondary	12-lead ECGs		Days 1 through 7	Yes
Secondary	Vital signs		Days 1 through 7	Yes

External Links

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