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.
- healthy
- male or female adults
- Current or history of clinically significant medical illness
- Smokers
- Illicit drug use
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Evaluating The Effects Of Cimetidine On The Elimination Of PD 0332334 From The Body | |||
| Official Title ICMJE | 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 | |||
| 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. | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) | |||
| Condition ICMJE | Generalized Anxiety Disorder | |||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Terminated | |||
| Actual Enrollment ICMJE | 12 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | February 2009 | |||
| Actual Primary Completion Date | February 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 55 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | United States | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00800280 | |||
| Other Study ID Numbers ICMJE | A5361030 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
| Study Sponsor ICMJE | Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
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| PRS Account | Pfizer | |||
| Verification Date | February 2010 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
