Status:
COMPLETED
Pharmacokinetic Properties of Lorcaserin in Subjects With Hepatic Impairment
Lead Sponsor:
Eisai Inc.
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate and establish whether lorcaserin dose adjustment is required in patients with mild or moderate hepatic impairment.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2008
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00828932
Start Date
August 1 2008
End Date
December 1 2008
Last Update
September 12 2019
Active Locations (1)
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1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809