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

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Generalized Anxiety Disorder

Treatments: Drug: Metformin; Drug: PD 0332334

Study type: Interventional

Funder types: Industry

Identifiers

NCT00809536

A5361031

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 21 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Nonsmokers
• Male or female adults

Exclusion criteria

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

Trial design

24 participants in 2 patient groups

Cohort 1

Other group

Description:

This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults

Treatment:

Drug: Metformin

Drug: Metformin

Cohort 2

Other group

Description:

This is an open-label, randomized, two period cross-over which will be conducted in 12 healthy adults

Treatment:

Drug: PD 0332334

Drug: PD 0332334