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

Phase 1

Completed

• Conditions: Obesity
• Interventions: Drug: CP-945,598

• Registration Number: NCT00472836
• Lead Sponsor: Pfizer

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 available

Study Timeline

• Study First Submitted: 2007-05-11
• Study First Submitted QC: 2007-05-11
• Study First Posted: 2007-05-14
• Study Start: 2007-06
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Status Verified: 2008-11
• Disposition First Submitted: 2009-08-11
• Disposition First Submitted QC: 2009-08-11
• Last Update Submitted: 2009-08-11
• Disposition First Posted: 2009-08-13
• Last Update Posted: 2009-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal renal function	CP-945,598	-
Severe renal impairment	CP-945,598	-

Primary Outcome Measures

Name	Time	Method
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,	14 days
28, 35	14 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 Miami, Florida, United States