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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00809536

Enrollment

Registered

2008-12-17

Start date

2009-01-31

Completion date

2009-02-28

Last updated

2010-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Generalized Anxiety Disorder

Keywords

metformin, PD 0332334, organic cation transporter, OCT2, pharmacokinetics

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.

Interventions

DRUGMetformin

225 mg q12, oral PD 0332334 immediate release formulation on Days 1 through 5; Single, oral, 500 mg dose of metformin immediate release

DRUGPD 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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* Nonsmokers * Male or female adults

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Clinical safety laboratories	Days 1 through 7
Vital signs	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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026