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

This study has been completed.
Sponsor:
Collaborators:
Covance
Sentrx
Information provided by:
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00768209
First received: October 6, 2008
Last updated: November 30, 2009
Last verified: November 2009
History of Changes
  Purpose

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 Intervention Phase
Hepatic Impairment
 Drug: Phentermine and Topiramate
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 9 days ] [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: October 2008
Study Completion Date: July 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768209

Locations
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
VIVUS, Inc.
Covance
Sentrx
Investigators
Study Director: Shiyin Yee, PhD VIVUS, Inc.
  More Information

No publications provided

Responsible Party: Wesley Day, VP Clinical, Vivus, Inc.
ClinicalTrials.gov Identifier: NCT00768209     History of Changes
Other Study ID Numbers: OB-105
Study First Received: October 6, 2008
Last Updated: November 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:
Pharmacokinetics

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases
Phentermine
Topiramate
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Appetite Depressants
 Anti-Obesity Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on May 16, 2013