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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00645021
Recruitment Status : Completed
First Posted : March 27, 2008
Last Update Posted : August 27, 2009
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Obesity Hepatic Insufficiency Drug: CP-945,598 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : October 2008

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Safety laboratory tests (chemistry, hematology, urinalysis) on days 0, 7, 15, 35 [ Time Frame: 14 days ]
  2. Adverse event monitoring throughout duration of the study [ Time Frame: 14 days ]
  3. Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 7, and 14 [ Time Frame: 14 days ]
  4. ECGs on Days 1, 7, and 14 [ Time Frame: 14 days ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00645021

United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33169
Pfizer Investigational Site
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc. Identifier: NCT00645021     History of Changes
Other Study ID Numbers: A5351029
First Posted: March 27, 2008    Key Record Dates
Last Update Posted: August 27, 2009
Last Verified: November 2008

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