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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00645021
First received: March 21, 2008
Last updated: August 26, 2009
Last verified: November 2008
  Purpose

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.


Condition Intervention Phase
Obesity
Hepatic Insufficiency
Drug: CP-945,598
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Measurement of drug and metabolite concentrations in serum collected at various times over 24 hour dosing interval on Days 1 and 14, before daily dose on days 5-7, 13, following stopping of drug treatment on days 15-18, 21, 28, and 35 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety laboratory tests (chemistry, hematology, urinalysis) on days 0, 7, 15, 35 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Adverse event monitoring throughout duration of the study [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 7, and 14 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • ECGs on Days 1, 7, and 14 [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: April 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mild hepatic function Drug: CP-945,598
Administration of CP-945,598 in subjects with mild hepatic function
Experimental: Moderate hepatic function Drug: CP-945,598
Administration of CP-945,598 in subjects with moderate hepatic function
Experimental: Normal hepatic function Drug: CP-945,598
Administration of CP-945,598 in subjects with normal hepatic function

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00645021

Locations
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169
Pfizer Investigational Site
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00645021     History of Changes
Other Study ID Numbers: A5351029
Study First Received: March 21, 2008
Last Updated: August 26, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatic Insufficiency
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on November 24, 2014