NCT00645021

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Obesity
• Hepatic Insufficiency

Interventions

Type	Name	Description
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

Timeline

• Start date: 2008-04-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-03-27
• Last updated: 2009-08-27

Locations

2 sites across 1 country: United States