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

NCT00768209 | Completed Phase 1

• 1 other identifier: OB-105
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Hepatic Impairment

Keywords

Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics

  9 days

Study Arms (1)

Treatment A

EXPERIMENTAL

Drug: Phentermine and Topiramate

Interventions

Phentermine and Topiramate DRUG

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

Treatment A

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VIVUS LLC: lead
• Covance: collaborator
• Sentrx: collaborator

Study Sites (2)

Clinical Pharmacology of Miami

Miami, Florida, 33014-3616, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809-3017, United States

Location

MeSH Terms

Interventions

Qsymia

Study Officials

• Shiyin Yee, PhD

  VIVUS LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 8, 2008
• Study Start: October 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 1, 2009

Record last verified: 2009-11

Locations

US (2)