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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00472836

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 I

MedlinePlus related topics: Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Parallel Assignment, Pharmacokinetics Study
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:	July 2007
Study Completion Date:	October 2008

Arms	Assigned Interventions
Normal renal function: Experimental	Drug: CP-945,598 Administration of CP-945,598 in subjects with normal renal function.
Severe renal impairment: Experimental	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

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:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting: This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A5351038
Study First Received:	May 11, 2007
Last Updated:	April 23, 2009
ClinicalTrials.gov Identifier:	NCT00472836 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

Additional relevant MeSH terms:

Body Weight
Signs and Symptoms
Obesity

Nutrition Disorders
Overweight
Overnutrition

ClinicalTrials.gov processed this record on May 06, 2009