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

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

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.

Study Overview

• Status: Completed
• Conditions: Hepatic Impairment
• Intervention / Treatment: Drug: Phentermine and Topiramate

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33014-3616
      • Clinical Pharmacology of Miami
    • Orlando, Florida, United States, 32809-3017
      • Orlando Clinical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics	9 days

Collaborators and Investigators

• Sponsor: VIVUS LLC
• Collaborators: Covance; Sentrx

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: October 6, 2008
• First Submitted That Met QC Criteria: October 7, 2008
• First Posted (Estimate): October 8, 2008

Study Record Updates

• Last Update Posted (Estimate): December 1, 2009
• Last Update Submitted That Met QC Criteria: November 30, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Pharmacokinetics
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Hypoglycemic Agents; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anticonvulsants; Appetite Depressants; Anti-Obesity Agents; Central Nervous System Stimulants; Sympathomimetics; Topiramate; Phentermine
• Other Study ID Numbers: OB-105