A Study to Evaluate the Pharmacokinetics of VI-0521 Subjects With Renal Impairment
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
1 other identifier
interventional
32
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Oct 2008
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 7, 2008
CompletedFirst Posted
Study publicly available on registry
October 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2009
CompletedDecember 1, 2009
November 1, 2009
5 months
October 7, 2008
November 30, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Pharmacokinetics
9 days
Study Arms (1)
A
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- VIVUS LLClead
Study Sites (4)
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Clinical Pharmacology of Miami
Miami, Florida, 33014-3616, United States
Orlando Clinical Research Center
Orlando, Florida, 32809-3017, United States
DaVita Clinical Research
Minneapolis, Minnesota, 55404, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Shiyin Yee, PhD
VIVUS LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2008
First Posted
October 8, 2008
Study Start
October 1, 2008
Primary Completion
March 1, 2009
Study Completion
July 1, 2009
Last Updated
December 1, 2009
Record last verified: 2009-11