Obesity
Conditions
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.
Interventions
DRUGCP-945,598
Administration of CP-945,598 in subjects with normal renal function.
Sponsors
Pfizer
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Outcome results
None listed