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The purpose of this study is to evaluate and establish whether lorcaserin dose adjustment is required in patients with mild or moderate hepatic impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorcaserin 10mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorcaserin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary objective of this study is to evaluate the pharmacokinetic properties of lorcaserin in subjects with mild or moderate hepatic impairment compared to subjects with normal hepatic function. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and tolerability of lorcaserin |
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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:
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:
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
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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 |
|---|---|
| C506658 | lorcaserin |
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