Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body

A Phase 1, Open-Label, Randomized, Cross-Over Study To Estimate The Effects Of Steady-State Cimetidine On The Pharmacokinetics Of A Single Dose Of PD 0332334 In Healthy Subjects

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00800280

Enrollment

Registered

2008-12-02

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

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

Brief summary

The purpose of this study is to estimate the effects of multiple doses of cimetidine on the pharmacokinetics of a single dose of PD 0332334 and to evaluate the safety and tolerability of PD 0332334 when co-administered with cimetidine.

Detailed description

Detailed Description: Additional Study Purpose Details: Evaluate the effects of multiple doses of cimetidine on the pharmacokinetics (e.g., elimination from the body) of a single dose of PD 0332334. 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

DRUGPD 0332334

Single 300 mg dose of PD 0332334 immediate release capsules administered orally

DRUGcimetidine

600 mg q 6 hours cimetidine immediate release formulation administered orally on Days 1 through 5.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

* healthy * male or female adults

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
PD 0332334 area under the curve (AUC) from 0 to infinity (AUCinf)	4 to 6 days
PD 0332334 AUC from 0 to last quantifiable concentration (AUClast)	4 to 6 days
Half-life (t1/2) of PD 0332334	4 to 6 days
Maximum plasma concentration (Cmax) of PD 0332334	4 to 6 days

Secondary

Measure	Time frame
Evaluate the incidence, duration and severity of adverse events	4 to 6 days
Vital signs	4 to 6 days
Evaluate the discontinuation due to adverse events	4 to 6 days
Clinical safety labs	4 to 6 days
ECG	4 to 6 days

Countries

United States

Outcome results

None listed

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