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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00645021
• Other study ID #: A5351029
• Status: Completed
• Phase: Phase 1
• First received: March 21, 2008
• Last updated: August 26, 2009
• Start date: April 2008
• Est. completion date: October 2008

Study information

• Verified date: November 2008
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatic Insufficiency
• Obesity

Intervention

Drug:
• CP-945,598
Administration of CP-945,598 in subjects with mild hepatic function
• CP-945,598
Administration of CP-945,598 in subjects with moderate hepatic function
• CP-945,598
Administration of CP-945,598 in subjects with normal hepatic function

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		14 days	No
Secondary	Safety laboratory tests (chemistry, hematology, urinalysis) on days 0, 7, 15, 35		14 days	No
Secondary	Adverse event monitoring throughout duration of the study		14 days	No
Secondary	Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 7, and 14		14 days	No
Secondary	ECGs on Days 1, 7, and 14		14 days	No

External Links

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