A Study to Evaluate How VI-0521 Affect Cardiac Repolarization in Healthy Male and Female Volunteers

NCT00839891 | Completed Phase 1

• 1 other identifier: OB-118
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

• Determine whether VI-0521 has an effect on the electrical activity of the heart in healthy subjects.
• Find out how much VI-0521 is in the blood and any potential side effects on ECG's of healthy subjects after taking the study drugs.

Conditions

Torsades de Pointes

Keywords

TQT, QTc

Outcome Measures

Primary Outcomes (1)

• The primary objective of this study is to assess whether treatment with a potential therapeutic dose or a supra-therapeutic dose of VI-0521 has the potential to cause QT/QTc prolongation in healthy volunteers.

  25 days

Secondary Outcomes (1)

• A secondary objective is to demonstrate assay sensitivity by showing that the active control (moxifloxacin 400 mg) treatment, corrected for placebo, produces a QTc change >5 msec.

  25 Days

Study Arms (1)

3

PLACEBO COMPARATOR

Group 1: 56 subjects to receive active study drug (VI-0521) at steady state, PHEN/TPM 7.5/46 (a potential therapeutic dose), escalating to PHEN/TPM 22.5/138 (a supra-therapeutic dose); Group 2: 28 subjects to receive placebo preceded by a single oral dose of moxifloxacin on Day 2; Group 3: 28 subjects to receive placebo followed by a single oral dose of moxifloxacin on Day 24;

Drug: VI-0521

Interventions

VI-0521 DRUG

PHEN/TPM 7.5/46 mg (a potential therapeutic dose) PHEN/TPM 22.5/138 mg (a supra-therapeutic dose)

3

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females, aged 19 to 50 years, inclusive.
• Body mass index (BMI) between 24 and 30 kg/m2, inclusive.
• Subjects must be in good health, as determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations.
• Women of child-bearing potential should test negative for pregnancy, must use medically acceptable contraceptive methods

You may not qualify if:

• Male subjects with a resting QTcB or QTcF value \<320 msec or \>450 msec, and female subjects with a resting QTcB or QTcF value \<320 msec or \>470 msec, as measured at the screening visit.
• Subjects with clinically significant ECG abnormalities that may interfere with the accurate assessment of the QT interval, including intraventricular conduction delays (QRS \>120 msec) and complete bundle branch blocks.
• Subjects who have a history of, or risk factors for, Torsades de Pointes (TdP) (eg, heart failure, abnormal serum electrolytes), including a family history of arrhythmia, sudden death or long QT syndrome.
• Subjects with known clinically significant arrhythmias or rhythm disturbances observed on the screening ECG and confirmed by a subsequent 24-hour ECG Holter recording.
• Subjects who have a supine heart rate (HR) at screening outside 45 to 90 beats per minute (bpm) (measured following at least a 10-minute rest).
• Subjects suffering from, or with a history of, one or more of the following conditions: hypertension, impaired glucose tolerance, diabetes mellitus, renal disease, edema, stroke or neurological disorder, rheumatological disorder (including arthritis, joint or tendon abnormalities), pulmonary disorder (including personal history of asthma), cardiovascular disorder (including coronary heart disease, congestive heart failure, cardiomyopathy, and any valvular heart disease), hepatic disorder, or a history of any illness that, in the opinion of the Investigator, might confound the results of the study or pose additional risk to the subject by participation in the study.
• Subjects with a history of psychiatric disorders, including bipolar disorder, psychosis, previous episode(s) of major depression or current depression, history of suicidality or suicidal ideation.
• Subjects with a history of nephrolithiasis or cholelithiasis.
• Subjects with a history of glaucoma, increased intraocular pressure, or use of any medication to treat increased intraocular pressure.
• Laboratory values at screening that are outside the normal range for the site unless prior approval is obtained from the VIVUS, Inc. medical monitor or designee.
• Subjects who are currently regular users (including recreational use) of any illicit drugs or who have a history of drug (including alcohol) abuse within 1 year of screening.
• Subjects who drink excessive amounts (equivalent to \>4 cups of brewed coffee per day) of coffee, tea, cola or other caffeinated beverages within the 2 weeks prior to Day -1.
• Subjects with a positive urine drug test at screening and/or on Day -1 (eg, cocaine, amphetamines, barbiturates, opiates, benzodiazepines, cannabinoids).
• Subjects who consume excessive amounts of alcohol, defined as \>3 drinks (beer, wine or distilled spirits) of alcoholic beverages per day, have a history of alcohol abuse, or are unwilling to comply with the restricted use of alcohol during the study.
• Subjects with a positive test for ethanol at screening and/or on Day -1.

Sponsors & Collaborators

• VIVUS LLC: lead

Study Sites (1)

MDS Pharma Services

Phoenix, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Torsades de Pointes

Condition Hierarchy (Ancestors)

Tachycardia, Ventricular; Tachycardia; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Shiyin Yee, PhD

  Clinical Pharmacology Consultant

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 6, 2009
• First Posted: February 10, 2009
• Study Start: February 1, 2009
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: January 21, 2010

Record last verified: 2010-01

Locations

US (1)