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The purpose of this study is to evaluate the PK properties of lorcaserin in obese or overweight elderly subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lorcaserin | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lorcaserin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the single-dose pharmacokinetic (PK) parameters of lorcaserin in the obese or overweight Elderly (> 65) to those obtained from the obese or overweight Adult (18-65) |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the safety and tolerability of a single oral dose of lorcaserin in obese or overweight Elderly (> 65) subjects and obese or overweight Adult (18-65) subjects. |
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Inclusion Criteria:
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
Initiation of a new prescription medication within 1 month prior to screening with the following exceptions:
Use of SSRIs, SNRIs, and other medications must meet washout period.
Participated in any clinical study with an investigational drug, biologic, or device within 1 month prior to screening
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRI Worldwide - Lourdes Hospital | Willingboro | New Jersey | 08046 | 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 |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |