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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obesity
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00472836
Pfizer
Completed
Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental Drug

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Study Examining The Effect Of Renal Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
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
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Obesity
  • Drug: CP-945,598
    Administration of CP-945,598 in subjects with normal renal function.
  • Drug: CP-945,598
    Administration of CP-945,598 in subjects with severe renal impairment.
  • Experimental: Normal renal function
    Intervention: Drug: CP-945,598
  • Experimental: Severe renal impairment
    Intervention: Drug: CP-945,598
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
October 2008
October 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 70 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00472836
A5351038
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2008

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

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