Pharmacokinetic Properties of Lorcaserin in Subjects With Hepatic Impairment

Inclusion criteria

• Males or females aged between 18 and 75 years (inclusive)
• Able to give signed informed consent
• 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)
• All subjects will have a BMI of 27-45 kg/m2, inclusive.
• Eligible male and female patients must agree not to participate in a conception process
• Considered to be in stable health in the opinion of the Investigator.

Exclusion criteria

• Prior participation in any study of lorcaserin.
• Clinically significant new illness in the 1 month before screening
• 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
• 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
• 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
• Malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins)
• Initiation of a new prescription medication within 1 month prior to screening.
• 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.
• Use of SSRI's, SNRI's, and other medications must meet the required washout periods.
• Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to dosing