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

Last updated on May 11, 2018

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

NCT00645021
Pfizer
Completed
Study Examining The Effect Of Hepatic Impairment On Safety, Toleration And How The Body Processes An Experimental Drug

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Study Examining The Effect Of Hepatic 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 Impaired And Normal Hepatic Function
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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Obesity
  • Hepatic Insufficiency
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
October 2008
October 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00645021
A5351029
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

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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