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NCT Number: NCT00645021

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CP-945,598

Drug

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

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

    Time frame: 14 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 27, 2008
Registry last updated
Aug 27, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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