Pharmacokinetic Properties of Lorcaserin in Subjects With Renal Impairment
Primary Purpose
Renal Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Lorcaserin 10mg
Sponsored by
About this trial
This is an interventional other trial for Renal Impairment
Eligibility Criteria
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
Sites / Locations
- Orlando Clinical Research Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lorcaserin 10mg
Arm Description
Outcomes
Primary Outcome Measures
The primary objective of this study is to assess the pharmacokinetic properties of lorcaserin in subjects with mild, moderate or severe renal impairment as compared to subjects with normal renal function.
Secondary Outcome Measures
To evaluate the safety and tolerability of lorcaserin in subjects with renal impairment.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00828438
Brief Title
Pharmacokinetic Properties of Lorcaserin in Subjects With Renal Impairment
Official Title
A Phase 1, Open-Label, Single-Dose Study of the Pharmacokinetic Properties of Lorcaserin in Subjects With Renal Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the PK properties of lorcaserin in subjects with end stage renal disease (ESRD) who require dialysis and will be studied under dialysis and non-dialysis conditions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lorcaserin 10mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lorcaserin 10mg
Primary Outcome Measure Information:
Title
The primary objective of this study is to assess the pharmacokinetic properties of lorcaserin in subjects with mild, moderate or severe renal impairment as compared to subjects with normal renal function.
Secondary Outcome Measure Information:
Title
To evaluate the safety and tolerability of lorcaserin in subjects with renal impairment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28365033
Citation
Christopher RJ, Morgan ME, Tang Y, Anderson C, Sanchez M, Shanahan W. Pharmacokinetics and Tolerability of Lorcaserin in Special Populations: Elderly Patients and Patients with Renal or Hepatic Impairment. Clin Ther. 2017 Apr;39(4):837-848.e7. doi: 10.1016/j.clinthera.2017.03.004. Epub 2017 Mar 30.
Results Reference
derived
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Pharmacokinetic Properties of Lorcaserin in Subjects With Renal Impairment
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