Status:
COMPLETED
A Study to Evaluate the Pharmacokinetics of VI-0521 in Subjects With Hepatic Impairment
Lead Sponsor:
VIVUS LLC
Collaborating Sponsors:
Covance
Sentrx
Conditions:
Hepatic Impairment
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This study is designed to determine the effects of a single dose of the study medication in subjects with and without hepatic impairment. 18 to 24 subjects will participate by having multiple blood dr...
Detailed Description
This study will look at the effect of a single does of study medication in three groups. Each group will have 6 - 8 subjects with similar levels of hepatic impairment. Group 1 will have normal hepatic...
Eligibility Criteria
Inclusion
- A total of 18 to 24 subjects will be studied in 3 groups of 6-8 subjects per group. Group 1 will consist of 6-8 males or females with normal hepatic function, 18 to 65 years of age inclusive. Groups 2-3 will consist of 6-8 males or females per group with varying degree of stable hepatic impairment.
Exclusion
- Any Subject meeting the following criteria must be excluded from the trial:
- Known history of clinically significant arrhythmias.
- Acute illness, especially any infection, within 2 weeks of dosing.
- History or presence of:
- Alcoholism or drug abuse within the past 2 years.
- Hypersensitivity or idiosyncratic reaction to compounds related to the study drug or related compounds.
- Any History of Bipolar disorder or psychosis, history of psychiatric hospitalization, greater than one lifetime episode of major depression.
- Blood donation or significant blood loss within 56 days prior to Day 1.
- Plasma donation within 7 days prior to Day 1.
- Any subject who has participated in a previous clinical trial with VI-0521.
- Any subject who received an investigational drug within 30 days prior to dosing in this study.
- Any history of glaucoma, increased intraocular pressure, or medications to treat increased intraocular pressure.
- Serum creatinine \> 1.5 for male subjects, and \>1.4 for female subjects.
- History of kidney stones in the last 6 months
- Female subjects, who may be pregnant, or are lactating.
- Use of any drug that is known to have clinical significance in inhibiting or inducing liver enzymes involved in drug metabolism.
- Use of tobacco or nicotine products within last 6 months unless subject is hepatically-impaired.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00768209
Start Date
October 1 2008
End Date
July 1 2009
Last Update
December 1 2009
Active Locations (2)
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1
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014-3616
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809-3017