Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics of VI-0521 Subjects With Renal Impairment
Lead Sponsor:
VIVUS LLC
Conditions:
Renal Impairment
Eligibility:
All Genders
19-75 years
Phase:
PHASE1
Brief Summary
VI-0521, a fixed dose combination of immediate-release (IR) phentermine and controlled-release (CR) topiramate, is in Phase III clinical development as a potential therapy for obesity. In human, both ...
Detailed Description
This open-label, parallel-group, single dose, non-randomized study will be conducted at multiple sites in the United States in which up to 40 male and female subjects, 19-75 years of age (inclusive), ...
Eligibility Criteria
Inclusion
- Group 1 will consist of 8-10 males or females with normal renal function, 19-75 years of age, inclusive.
- Groups 2-4 will consist of 8-10 males or females per group with varying degree of stable renal impairment
Exclusion
- A history or presence of significant cardiovascular, neurological, hematological, psychiatric, hepatic, gastrointestinal, pulmonary, endocrine, immunologic or renal disease or other condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs or place the subjects at increased risk as determined by the investigator; any history of glaucoma, increased intraocular pressure, or medications to treat increased intraocular pressure; presence of cholelithiasis or cholecystitis within the last 6 months that has not been surgically treated with cholecystectomy; any history of a cardiovascular or cerebrovascular event; subjects requiring dialysis; any active malignancy except basal cell carcinoma; systolic blood pressure \> 180 mm Hg or diastolic blood pressure \> 100 mm Hg at screening or at check-in (2 rechecks are allowed); Hemoglobin \<12.0 g/dL for Group 1 (patients with normal renal function); Hemoglobin \<. 9.0 g/dL for Groups 2, 3 and 4 (patients with mild to severe renal function) positive drug/alcohol test at screening or check in; blood donation or significant blood loss within 56 days of dosing; plasma donation within 7 days of dosing. In female subjects, a positive pregnancy test at screening or check-in is exclusionary
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00768404
Start Date
October 1 2008
End Date
July 1 2009
Last Update
December 1 2009
Active Locations (4)
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1
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
2
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014-3616
3
Orlando Clinical Research Center
Orlando, Florida, United States, 32809-3017
4
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404