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

Condition(s) targeted: Generalized Anxiety Disorder

Intervention: Metformin (Drug); Metformin (Drug); PD 0332334 (Drug); PD 0332334 (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Overall contact:
Pfizer CT.gov Call Center, Phone: 1-800-718-1021

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.

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

Study design: Other, Randomized, Open Label, Crossover Assignment, Pharmacokinetics Study

Primary outcome:

Metformin and PD 0332334 area under the curve (AUC) from time 0 to infinity (AUCinf)

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

Metformin and PD 0332334 half-life (t1/2)

Metformin and PD 0332334 maximum plasma concentration

Secondary outcome:

Clinical safety laboratories

Incidence, duration and severity of adverse events when study medications administered alone and concurrently

Discontinuation due to adverse events when study medications administered alone and concurrently

12-lead ECGs

Vital signs

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

Minimum age: 21 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Nonsmokers

- Male or female adults

Exclusion Criteria:

- Current or history of significant medical illness

- Smokers

- Illicit drug use

Pfizer CT.gov Call Center, Phone: 1-800-718-1021

Pfizer Investigational Site, Singapore 188770, Singapore; Recruiting

To obtain contact information for a study center near you, click here.

Starting date: December 2008
Ending date: February 2009
Last updated: January 27, 2009