Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body
Phase 1
Terminated
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Registration Number
- NCT00800280
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
- healthy
- male or female adults
Exclusion Criteria
- Current or history of clinically significant medical illness
- Smokers
- Illicit drug use
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Single dose PD 0332334 PD 0332334 - Single dose PD 0332334 with steady-state cimetidine cimetidine - Single dose PD 0332334 with steady-state cimetidine PD 0332334 -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Evaluate the incidence, duration and severity of adverse events 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 Vital signs 4 to 6 days
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸New Haven, Connecticut, United States