search
Back to results

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

Primary Purpose

Obesity, Hepatic Insufficiency

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CP-945,598
CP-945,598
CP-945,598
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Mild hepatic function

Moderate hepatic function

Normal hepatic function

Arm Description

Outcomes

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

Secondary Outcome Measures

Safety laboratory tests (chemistry, hematology, urinalysis) on days 0, 7, 15, 35
Adverse event monitoring throughout duration of the study
Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 7, and 14
ECGs on Days 1, 7, and 14

Full Information

First Posted
March 21, 2008
Last Updated
August 26, 2009
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00645021
Brief Title
Study Examining The Effect Of Hepatic Impairment On Safety, Toleration And How The Body Processes An Experimental Drug
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 Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Hepatic Insufficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mild hepatic function
Arm Type
Experimental
Arm Title
Moderate hepatic function
Arm Type
Experimental
Arm Title
Normal hepatic function
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
CP-945,598
Intervention Description
Administration of CP-945,598 in subjects with mild hepatic function
Intervention Type
Drug
Intervention Name(s)
CP-945,598
Intervention Description
Administration of CP-945,598 in subjects with moderate hepatic function
Intervention Type
Drug
Intervention Name(s)
CP-945,598
Intervention Description
Administration of CP-945,598 in subjects with normal hepatic function
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Safety laboratory tests (chemistry, hematology, urinalysis) on days 0, 7, 15, 35
Time Frame
14 days
Title
Adverse event monitoring throughout duration of the study
Time Frame
14 days
Title
Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 7, and 14
Time Frame
14 days
Title
ECGs on Days 1, 7, and 14
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Pfizer Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5351029&StudyName=Study%20Examining%20The%20Effect%20Of%20Hepatic%20Impairment%20On%20Safety%2C%20Toleration%20And%20How%20The%20Body%20Processes%20An%20Experimental%20Drug
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

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

We'll reach out to this number within 24 hrs