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

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Pfizer

Status and phase

Completed
Phase 1

Conditions

Obesity

Treatments

Drug: CP-945,598

Study type

Interventional

Funder types

Industry

Identifiers

NCT00472836
A5351038

Details and patient eligibility

About

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.

Enrollment

17 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

17 participants in 2 patient groups

Normal renal function
Experimental group
Treatment:
Drug: CP-945,598
Severe renal impairment
Experimental group
Treatment:
Drug: CP-945,598

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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