Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental Drug

• ClinicalTrials.gov Identifier: NCT00472836
• Recruitment Status: Completed
• First Posted: May 14, 2007
• Last Update Posted: August 13, 2009
• Sponsor: Pfizer
• Information provided by: Pfizer

Tracking Information

• First Submitted Date: May 11, 2007
• First Posted Date: May 14, 2007
• Last Update Posted Date: August 13, 2009
• Study Start Date: June 2007
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 25, 2008)

• Measurement of drug and metabolite concentrations in serum from blood samples collected at various times over 24 hour dosing interval on Days 1 & 14, before daily dose on days 2, 5-7, 13, following stopping of drug treatment on days 15-18, 21, [ Time Frame: 14 days ]
• 28, 35 [ Time Frame: 14 days ]

• Original Primary Outcome Measures (submitted: May 11, 2007): Measurement of drug and metabolite concentrations in serum from blood samples collected at various times over 24 hour dosing interval on Days 1 & 14, before daily dose on days 2, 5-7, 13, following stopping of drug treatment on days 15-18, 21, 28, 35

Current Secondary Outcome Measures (submitted: December 21, 2007)

• Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 2, 7, and 14 [ Time Frame: 14 days ]
• ECGs on Days 1,7 and 14 [ Time Frame: 14 days ]
• Safety laboratory tests (Chemistry, hematology, urinalysis) on Days 2, 7, 14 and 35 [ Time Frame: 14 days ]
• Adverse event monitoring throughout duration of the study [ Time Frame: 14 days ]

• Original Secondary Outcome Measures (submitted: May 11, 2007): Vital signs (Blood pressure, heart rate and respiratory rate) on days 1, 2, 7, and 14 ECGs on Days 1,7 and 14 Safety laboratory tests (Chemistry, hematology, urinalysis) on Days 2, 7, 14 and 35 Adverse event monitoring throughout duration of the study
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
• Official Title: A Phase 1, Open-Label, Parallel Group, Multiple-Dose Study To Evaluate The Pharmacokinetics, Safety And Toleration Of CP-945,598 Administered To Subjects With Severely Impaired And Normal Renal Function
• Brief Summary: CP-945,598 is eliminated following extensive metabolism. For some drugs, decreased renal (kidney) function can affect their elimination from the body via metabolism. This study will therefore compare the pharmacokinetics (time course of drug concentrations in the body), safety and tolerability of CP-945,598 in patients with severe renal impairment and healthy control subjects.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Obesity

Intervention

• Drug: CP-945,598
  Administration of CP-945,598 in subjects with normal renal function.
• Drug: CP-945,598
  Administration of CP-945,598 in subjects with severe renal impairment.

Study Arms

• Experimental: Normal renal function
  Intervention: Drug: CP-945,598
• Experimental: Severe renal impairment
  Intervention: Drug: CP-945,598

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 23, 2009): 17
• Original Enrollment (submitted: May 11, 2007): 16
• Actual Study Completion Date: October 2008
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Normal Subjects: 1.Healthy. 2.Matched for age (± 5 yrs), weight (± 10 kg), and gender ratio (± 2 subjects per gender).
• Subjects with Renal Disease: 1. Severe impairment (Creatinine clearance <30 mL/min) 2. Stable renal disease:no change in the last 30 days. 3. Stable dose of medication and/or treatment. 4. Reasonably well-controlled type 1 and type 2 diabetics

Exclusion Criteria:

• All subjects: Non-prescribed use of drugs of abuse/ recreational drugs; recent treatment with experimental drugs or herbal experiments; EKG and blood pressure parameters falling outside of protocol-specified limits; history of regular alcohol or tobacco use exceeding protocol-specified limits
• Normal subjects: Medically important health conditions; recent use of prescription or non-prescription medications.
• Subjects with renal disease: Subjects requiring dialysis; certain chronic medical conditions; patients who have received renal transplant; severe and/or poorly controlled diabetes; Treatment with protocol-specified drugs that may alter the way the body absorbs or processes CP-945,598.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 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: NCT00472836
• Other Study ID Numbers: A5351038
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

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

• PRS Account: Pfizer
• Verification Date: November 2008