Back to resultsA Study to Evaluate the Pharmacokinetics of VI-0521 Subjects With Renal Impairment
Primary Purpose
Renal Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Topirmate and Phentermine
Sponsored by
About this trial
This is an interventional treatment trial for Renal Impairment
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Sites / Locations
- Advanced Clinical Research Institute
- Clinical Pharmacology of Miami
- Orlando Clinical Research Center
- DaVita Clinical Research
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
A
Arm Description
Outcomes
Primary Outcome Measures
Pharmacokinetics
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00768404
Brief Title
A Study to Evaluate the Pharmacokinetics of VI-0521 Subjects With Renal Impairment
Official Title
A Phase I, Open-Label, Parallel-Group, Single Dose, Non-Randomized Study To Compare The Pharmacokinetics Of Each Individual Component (Topiramate And Phentermine) Of The Combination Product VI-0521 In Subjects With Mild, Moderate And Severe Renal Impairment To Subjects With Normal Renal Function
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
VIVUS LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 phentermine and topiramate are primarily cleared by renal excretion. The contribution of hepatic metabolism to elimination of phentermine and topiramate is not significant. Obese patients, the proposed indicated population for future treatment with VI-0521, are likely to have renal impairment. Therefore, this study is important in understanding the effect of renal impairment on the pharmacokinetics of topiramate and phentermine in subjects with renal impairment compared to subjects with normal renal function.
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), with varying degrees of renal function may be enrolled and dosed to obtain at least 32 evaluable subjects (4 groups, 8 subjects per group). Subjects will report to the study site on the evening before treatment and will remain at the site until the 48-hour PK sample has been drawn (approximately 3 days). All subjects will be fasted overnight for a minimum of 8 hours before drug treatment in the morning. A single oral dose of the combination product VI-0521 (15 mg phentermine and 92 mg topiramate) will be administered with 240 mL of water at hour 0. Standard meals will be provided uniformly to all subjects at approximately 4 and 9 hours after dosing, and an evening snack will be provided approximately 12 - 13 hours after dosing. Blood samples for the determination of phentermine and topiramate concentrations in plasma will be collected at 0 (pre-dose), 1, 3, 4, 5, 6, 7, 8, 9, 10, 12, 16, 24, 36 and 48 hours post dosing. Subjects will be released from the study site following the 48-hour sample but will return to the site for PK sampling at 72, 96, 120, 144, 168 and 192 hours post dose. The severe renal impairment group will be given the option to stay at the site for the duration of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Topirmate and Phentermine
Intervention Description
A single oral dose of the combination product VI-0521 (15 mg phentermine and 92 mg topiramate) will be administered with 240 mL of water at hour 0.
Primary Outcome Measure Information:
Title
Pharmacokinetics
Time Frame
9 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyin Yee, PhD
Organizational Affiliation
VIVUS LLC
Official's Role
Study Director
Facility Information:
Facility Name
Advanced Clinical Research Institute
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Clinical Pharmacology of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33014-3616
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809-3017
Country
United States
Facility Name
DaVita Clinical Research
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate the Pharmacokinetics of VI-0521 Subjects With Renal Impairment
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