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Sponsored by: |
Arena Pharmaceuticals |
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Information provided by: | Arena Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00828438 |
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.
Condition | Intervention | Phase |
---|---|---|
Renal Impairment |
Drug: Lorcaserin 10mg |
Phase I |
Study Type: | Interventional |
Study Design: | Open Label, Single Group Assignment, Pharmacokinetics Study |
Official Title: | A Phase 1, Open-Label, Single-Dose Study of the Pharmacokinetic Properties of Lorcaserin in Subjects With Renal Impairment |
Estimated Enrollment: | 40 |
Study Start Date: | October 2008 |
Study Completion Date: | February 2009 |
Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Lorcaserin 10mg: Experimental | Drug: Lorcaserin 10mg |
Ages Eligible for Study: | 18 Years to 79 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Renal function will fall into one of the following categories (ideal body weight will be used for the calculation):
Exclusion Criteria:
History of any of the following cardiovascular conditions:
United States, Florida | |
Orlando Clinical Research Center | |
Orlando, Florida, United States, 32809 |
Investigator: | Christen Anderson, MD,PhD | Arena Pharmaceuticals |
Responsible Party: | Arena Pharmaceuticals, Inc. ( Christen Anderson, MD, PhD ) |
Study ID Numbers: | APD356-016 |
Study First Received: | January 22, 2009 |
Last Updated: | July 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00828438 History of Changes |
Health Authority: | United States: Food and Drug Administration |