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

NCT00645021 | Completed Phase 1

• 1 other identifier: A5351029
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity; Hepatic Insufficiency

Outcome Measures

Primary Outcomes (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

  14 days

Secondary Outcomes (4)

• Safety laboratory tests (chemistry, hematology, urinalysis) on days 0, 7, 15, 35

  14 days

• Adverse event monitoring throughout duration of the study

  14 days

• Vital signs (blood pressure, heart rate and respiratory rate) on days 1, 7, and 14

  14 days

• ECGs on Days 1, 7, and 14

  14 days

Study Arms (3)

Mild hepatic function

EXPERIMENTAL

Drug: CP-945,598

Moderate hepatic function

EXPERIMENTAL

Drug: CP-945,598

Normal hepatic function

EXPERIMENTAL

Drug: CP-945,598

Interventions

CP-945,598 DRUG

Administration of CP-945,598 in subjects with mild hepatic function

Mild hepatic function

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

Pfizer Investigational Site

Miami, Florida, 33169, United States

Location

Pfizer Investigational Site

Orlando, Florida, 32809, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Obesity; Hepatic Insufficiency

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Liver Diseases; Digestive System Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 21, 2008
• First Posted: March 27, 2008
• Study Start: April 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 27, 2009

Record last verified: 2008-11

Locations

US (2)