A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function

• ClinicalTrials.gov Identifier: NCT00596518
• Recruitment Status: Completed
• First Posted: January 17, 2008
• Last Update Posted: March 10, 2017
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: January 8, 2008
• First Posted Date: January 17, 2008
• Last Update Posted Date: March 10, 2017
• Study Start Date: October 2007
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 8, 2008)

• Area under the curve from time 0 until last observation (AUCtlast) [ Time Frame: 3-6 days ]
• Maximum serum concentration (Cmax) [ Time Frame: 3-6 days ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 8, 2008)

• AUC extrapolated to infinity (AUCinf) [ Time Frame: 3-6 days ]
• Time of Cmax (Tmax) [ Time Frame: 3-6 days ]
• Half life (T1/2) [ Time Frame: 3-6 days ]
• Renal clearance (CLr) [ Time Frame: 3-6 days ]
• Hemodialysis clearance (CLd) [ Time Frame: 3 days ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function
• Official Title: A Phase 1, Open-Label Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of PF-00734200 Administered To Subjects With Various Degrees Of Renal Impairment And Normal Renal Function
• Brief Summary: The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200 in subjects with various degrees of kidney function or undergoing chronic hemodialysis will be assessed.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Renal Insufficiency, Chronic

Intervention

Drug: PF-00734200

The drug is administered as a single dose of four 5-mg tablets

Study Arms

Experimental: PF-00734200

Intervention: Drug: PF-00734200

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 8, 2008): 30
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2008
• Actual Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Subjects must meet one of the following renal function categories Normal renal function Mild renal impairment Moderate renal impairment End stage renal disease requiring chronic hemodialysis
2. Body mass index between approximately 18-40 kg/m2 inclusive, and a total body weight greater than 50 kg
3. Subjects in the normal renal function category must be healthy and not receiving any chronic treatment with prescription or non-prescription medications

Exclusion Criteria:

1. Women who are pregnant, nursing or women of childbearing potential
2. Subjects with acute renal disease.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 77 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00596518
• Other Study ID Numbers: A7941014
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: March 2017