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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Obesity

Intervention / Treatment
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* Drug: CP-945,598
* Drug: CP-945,598


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal renal function<br> | Drug: CP-945,598<br>* Administration of CP-945,598 in subjects with normal renal function.<br>|
| Experimental: Severe renal impairment<br> | Drug: CP-945,598<br>* Administration of CP-945,598 in subjects with severe renal impairment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |