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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00472836
First received: May 11, 2007
Last updated: August 11, 2009
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Obesity
Drug: CP-945,598
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 28, 35 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 2, 7, and 14 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • ECGs on Days 1,7 and 14 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Safety laboratory tests (Chemistry, hematology, urinalysis) on Days 2, 7, 14 and 35 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Adverse event monitoring throughout duration of the study [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 17
Study Start Date: June 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Normal renal function Drug: CP-945,598
Administration of CP-945,598 in subjects with normal renal function.
Experimental: Severe renal impairment Drug: CP-945,598
Administration of CP-945,598 in subjects with severe renal impairment.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472836

Locations
United States, California
Pfizer Investigational Site
Anaheim, California, United States, 92801
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00472836     History of Changes
Other Study ID Numbers: A5351038
Study First Received: May 11, 2007
Last Updated: August 11, 2009
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 30, 2014