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A Study to Evaluate the Pharmacokinetics of VI-0521 in Subjects With Hepatic Impairment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00768209
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : December 1, 2009
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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 draws taken to measure the level of study medication in their blood over time.

Condition or disease Intervention/treatment Phase
Hepatic Impairment Drug: Phentermine and Topiramate Phase 1

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 function. Groups 2 and 3 will be made up of subjects with mild to moderate hepatic impairment. Subjects will have blood taken at specific intervals to measure study medication levels. Subject participation will last approximately 7 to 9 days.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open Label, Single-Dose Study to Evaluate the Pharmacokinetics of VI-0521 in Subjects With Hepatic Impairment and In Healthy Control Subjects
Study Start Date : October 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment A Drug: Phentermine and Topiramate
Each subject will be dosed with a single oral dose of VI-0521 (PHEN/TPM 15/92 mg).

Primary Outcome Measures :
  1. Pharmacokinetics [ Time Frame: 9 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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 Criteria:

Any Subject meeting the following criteria must be excluded from the trial:

  1. Known history of clinically significant arrhythmias.
  2. Acute illness, especially any infection, within 2 weeks of dosing.
  3. 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.
  4. Any History of Bipolar disorder or psychosis, history of psychiatric hospitalization, greater than one lifetime episode of major depression.
  5. Blood donation or significant blood loss within 56 days prior to Day 1.
  6. Plasma donation within 7 days prior to Day 1.
  7. Any subject who has participated in a previous clinical trial with VI-0521.
  8. Any subject who received an investigational drug within 30 days prior to dosing in this study.
  9. Any history of glaucoma, increased intraocular pressure, or medications to treat increased intraocular pressure.
  10. Serum creatinine > 1.5 for male subjects, and >1.4 for female subjects.
  11. History of kidney stones in the last 6 months
  12. Female subjects, who may be pregnant, or are lactating.
  13. Use of any drug that is known to have clinical significance in inhibiting or inducing liver enzymes involved in drug metabolism.
  14. Use of tobacco or nicotine products within last 6 months unless subject is hepatically-impaired.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00768209

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United States, Florida
Clinical Pharmacology of Miami
Miami, Florida, United States, 33014-3616
Orlando Clinical Research Center
Orlando, Florida, United States, 32809-3017
Sponsors and Collaborators
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Study Director: Shiyin Yee, PhD VIVUS, Inc.

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Responsible Party: Wesley Day, VP Clinical, Vivus, Inc. Identifier: NCT00768209     History of Changes
Other Study ID Numbers: OB-105
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: December 1, 2009
Last Verified: November 2009
Keywords provided by VIVUS, Inc.:
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Central Nervous System Stimulants
Appetite Depressants
Anti-Obesity Agents
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action