Pharmacokinetic Properties of Lorcaserin in Subjects With Hepatic Impairment

Launched by EISAI INC. · Jan 23, 2009

Keywords

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Gender

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Eligibility criteria

• Inclusion Criteria:
• • 1. Males or females aged between 18 and 75 years (inclusive)
• • 2. Able to give signed informed consent
• 3. Hepatic function will fall into one of the following categories:
• • One-third of patients will have normal hepatic function (defined as having all of the following parameters within the normal range of the clinical laboratory used for this trial: AST, ALT, alkaline phosphatase, total bilirubin)
• • One-third of patients will have mild impairment (Child-Pugh score 5-6)
• • One-third of patients will have moderate impairment (Child-Pugh score 7-9)
• • 4. All subjects will have a BMI of 27-45 kg/m2, inclusive.
• • 5. Eligible male and female patients must agree not to participate in a conception process
• • 6. Considered to be in stable health in the opinion of the Investigator.
• Exclusion Criteria:
• • 1. Prior participation in any study of lorcaserin.
• • 2. Clinically significant new illness in the 1 month before screening
• • 3. Not suitable to participate in the study in the opinion of the Investigator including an existing physical or mental condition that prevents compliance with the protocol
• 4. History of any of the following cardiovascular conditions:
• • Myocardial infarction (diagnosed by cardiac enzyme\[s\] and/or diagnostic ECG), CVA, TIA or RIND within 6 months of screening
• • Cardiac arrhythmia requiring initiation of new medical or surgical treatment within 6 months of screening (stable medical therapy for \> 6 months, pacemakers and/or defibrillators implanted \> 6 months prior to screening are acceptable)
• • Unstable angina
• • 5. Surgically implanted portacaval shunts are excluded with the following exception: transjugular intrahepatic portosystemic shunts (TIPS) will be allowed if placed no less than 3 months prior to dosing
• • 6. Malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins)
• • 7. Initiation of a new prescription medication within 1 month prior to screening.
• • 8. Recent history (within 3 months prior to the screening visit) of alcohol or drug/solvent abuse or a positive screen for drugs of abuse at screening.
• • 9. Use of SSRI's, SNRI's, and other medications must meet the required washout periods.
• • 10. Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to dosing