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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorcaserin 10mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorcaserin 10mg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of lorcaserin in subjects with renal impairment. |
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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):
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:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28365033 | Derived | 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. |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |