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

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NCT00645021

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Study Location
Pfizer Investigational Site
Miami, Florida, 33169, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Obesity, Hepatic Insufficiency
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy:Matched for age (± 5 years), weight (± 10 kg), and gender (±2 subjects per gender)

- Subjects with hepatic disease: 1. mild impairment (child-pugh score 5-6), moderate (child-pugh score 7-9). 2. stable hepatic disease: no changes in the last 30 days. 3. stable dose of medication and/or treatment.

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; ECG and blood pressure
falling outside of protocol-specified limits; history of regular tobacco use exceeding
protocol-specified limits


- Normal subjects: medically important health conditions; recent use of prescription or
non-prescription medications; history of regular alcohol use exceeding
protocol-specified limits


- Subjects with hepatic disease: child-puge score greater than 9; hepatic carcinoma and
hepatorenal syndrome;Undergone porta-caval shunt surgery; History of GI hemorrhage due
to esophageal varices or peptic ulcers less than 1 month prior to study entry;
significant hepatic encephalopathy; severe ascites and/or pleural effusion; Positive
blood alcohol test/alcohol breathalyzer at screening or on Day 0.

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Obesity, Hepatic InsufficiencyStudy Examining The Effect Of Hepatic Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
NCT00645021
  1. Miami, Florida
  2. Orlando, Florida
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study Examining The Effect Of Hepatic Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
Official Title  ICMJE 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 Impaired And Normal Hepatic Function
Brief Summary CP-945,598 is eliminated following extensive metabolism. Decrease hepatic function can affect its 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 mild and moderate hepatic impairment and healthy control subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Obesity
  • Hepatic Insufficiency
Intervention  ICMJE
  • Drug: CP-945,598
    Administration of CP-945,598 in subjects with mild hepatic function
  • Drug: CP-945,598
    Administration of CP-945,598 in subjects with moderate hepatic function
  • Drug: CP-945,598
    Administration of CP-945,598 in subjects with normal hepatic function
Study Arms  ICMJE
  • Experimental: Mild hepatic function
    Intervention: Drug: CP-945,598
  • Experimental: Moderate hepatic function
    Intervention: Drug: CP-945,598
  • Experimental: Normal hepatic function
    Intervention: Drug: CP-945,598
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2008)		24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2008
Actual Primary Completion Date October 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy:Matched for age (± 5 years), weight (± 10 kg), and gender (±2 subjects per gender)
  • Subjects with hepatic disease: 1. mild impairment (child-pugh score 5-6), moderate (child-pugh score 7-9). 2. stable hepatic disease: no changes in the last 30 days. 3. stable dose of medication and/or treatment.

Exclusion Criteria:

  • All subjects: Non-prescribed use of drugs of abuse/recreational drugs; recent treatment with experimental drugs or herbal experiments; ECG and blood pressure falling outside of protocol-specified limits; history of regular tobacco use exceeding protocol-specified limits
  • Normal subjects: medically important health conditions; recent use of prescription or non-prescription medications; history of regular alcohol use exceeding protocol-specified limits
  • Subjects with hepatic disease: child-puge score greater than 9; hepatic carcinoma and hepatorenal syndrome;Undergone porta-caval shunt surgery; History of GI hemorrhage due to esophageal varices or peptic ulcers less than 1 month prior to study entry; significant hepatic encephalopathy; severe ascites and/or pleural effusion; Positive blood alcohol test/alcohol breathalyzer at screening or on Day 0.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00645021
Other Study ID Numbers  ICMJE A5351029
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP