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

NCT ID: NCT00768209

Last Updated: 2009-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatic Impairment

Keywords

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Pharmacokinetics

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment A

Group Type EXPERIMENTAL

Phentermine and Topiramate

Intervention Type DRUG

Each subject will be dosed with a single oral dose of VI-0521 (PHEN/TPM 15/92 mg).

Interventions

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Phentermine and Topiramate

Each subject will be dosed with a single oral dose of VI-0521 (PHEN/TPM 15/92 mg).

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Covance

INDUSTRY

Sponsor Role collaborator

Sentrx

INDUSTRY

Sponsor Role collaborator

VIVUS LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Vivus, Inc.

Principal Investigators

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Shiyin Yee, PhD

Role: STUDY_DIRECTOR

VIVUS LLC

Locations

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Clinical Pharmacology of Miami

Miami, Florida, United States

Site Status

Orlando Clinical Research Center

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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OB-105

Identifier Type: -

Identifier Source: org_study_id