- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00721422
A Single Dose Study Investigating the Elimination as Well as the Tolerability of PD 0332334 in Healthy Subjects as Compared to Patients With Impaired Kidney Function.
A Phase 1, Open-Label, Single Dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PD 0332334 In Subjects With Various Degrees Of Renal Function
- To investigate the effect of kidney function on the elimination of a single dose of PD 0332334 from the body.
- To investigate the safety and tolerability of a single dose of PD 0332334 in patients with impaired kidney function.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Additional Study Purpose Details: Investigation of the pharmacokinetics, safety, and tolerability of a single dose of PD 0332334 in patients with impaired renal function.
On February 23rd 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
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Cypress, California, United States, 90630
- Pfizer Investigational Site
-
-
Florida
-
Miami, Florida, United States, 33169
- Pfizer Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Healthy volunteers OR subjects with kidney impairment
Exclusion Criteria:
- Receiving hemodialysis
- clinically significant or unstable medical disease other than kidney disease
Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1-Normal
|
50 mg (two 25 mg capsules), single, oral dose
Other Names:
|
Experimental: Group 2-Mild
|
50 mg (two 25 mg capsules), single, oral dose
Other Names:
|
Experimental: Group 3-Moderate
|
50 mg (two 25 mg capsules), single, oral dose
Other Names:
|
Experimental: Group 4-Severe
|
50 mg (two 25 mg capsules), single, oral dose
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
maximum plasma concentration (Cmax), time of maximum plasma concentration (Tmax), and apparent clearance from plasma (CL/F)
Time Frame: 1 day
|
1 day
|
amount of PD 0332334 eliminated unchanged in urine during the 96-hour collection period (Ae96)
Time Frame: 5 days
|
5 days
|
PD 0332334 area under the curve from 0 to infinity (AUCinf), PD 0332334 area under the curve from 0 to last quantifiable concentration (AUClast),
Time Frame: 5 to 17 days depending on cohort
|
5 to 17 days depending on cohort
|
PD 0332334 renal clearance (CLr), apparent volume of distribution (Vz/F), terminal half life (t1/2),
Time Frame: 5 to 17 days depending on cohort
|
5 to 17 days depending on cohort
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events, ECG, physical exams, clinical safety laboratory, and vital signs
Time Frame: 5 to 17 days
|
5 to 17 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A5361023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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