Status:
COMPLETED
A Study to Evaluate How VI-0521 Affect Cardiac Repolarization in Healthy Male and Female Volunteers
Lead Sponsor:
VIVUS LLC
Conditions:
Torsades de Pointes
Eligibility:
All Genders
19-50 years
Phase:
PHASE1
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 su...
Detailed Description
This three-arm, parallel group, double-blind, active- and placebo-controlled study comparing VI-0521 at a potential therapeutic dose of PHEN/TPM 7.5/46 and PHEN/TPM 22.5/138 , a supra-therapeutic dose...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT00839891
Start Date
February 1 2009
End Date
April 1 2009
Last Update
January 21 2010
Active Locations (1)
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1
MDS Pharma Services
Phoenix, Arizona, United States, 85283