Pharmacokinetic Properties of Lorcaserin in Subjects With Renal Impairment

Inclusion criteria

• Males or females aged between 18 and 79 years (inclusive)
• Able to give signed informed consent
• Renal function will fall into one of the following categories (ideal body weight will be used for the calculation):

• One-fifth of subjects will have normal renal function, defined as creatinine clearance > 80 mL/min calculated using the Cockroft-Gault equation
• One-fifth of subjects will have creatinine clearance 51-80 mL/min
• One-fifth of subjects will have creatinine clearance 31-50 mL/min
• One-fifth of subjects will have creatinine clearance 5-30 mL/min, but not require dialysis
• One-fifth of subjects will have chronic end stage renal disease, require regularly scheduled hemodialysis, and be on a stable hemodialysis regimen for at least 3 months prior to dosing
• Subjects in the renally impaired groups will have stable renal disease as per Investigator's assessment, with no clinically meaningful changes for 1 month prior to randomization.
• Subjects in all groups will have a BMI of 27-45 kg/m2.
• Considered to be in stable health in the opinion of the Investigator.
• Eligible male and female subjects must agree not to participate in a conception process.

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 3 months of screening
• Cardiac arrhythmia requiring initiation of a new medical or surgical treatment within 3 months of screening (pacemaker and/or defibrillator implanted > 3 months prior to screening is acceptable)
• Unstable angina
• History of pulmonary artery hypertension
• Positive result of HIV, hepatitis B or hepatitis C screens.
• Malignancy within 2 years of the screening visit (except basal cell or squamous cell carcinoma with clean surgical margins)
• Use of SSRI's, SNRI's, and other medications must meet washout period.
• 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.
• Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to dosing
• Unwilling, or whose partner is unwilling, to use an adequate means of contraception during and for 1 month following completion/withdrawal of the study