Nebivolol is one of a class of drugs known as beta-blockers. These drugs are useful in the treatment of high blood pressure, angina, abnormal heart rhythms and following a heart attack. The purpose of this study is to explore the potential of nebivolol to cause a certain type of abnormal heart rhythm, known as QTc prolongation. The potential of nebivolol to cause this adverse event will be compared to three other drugs: atenolol, a beta-blocker approved by the FDA; Avelox (moxifloxacin), an anti-biotic approved for use by the FDA which is known to cause QTc prolongation; and placebo, a drug look-alike that contains no drug. The working hypothesis was that 20 or 40 mg of nebivolol would not prolong corrected QT intervals measured during peak nebivolol concentrations (i.e., 2 hours after dosing) on Day 7.

Condition	Intervention	Phase
Hypertension	Drug: Nebivolol  Drug: Atenolol  Drug: Moxifloxacin	Phase I

Further Study Details: 

Primary Outcomes: The primary study endpoint was the change in the average QTc intervals from Day 0 to 2 hours after dosing on Day 7.
Secondary Outcomes: The secondary endpoints were the change in average QTc intervals from Day 0 to all other evaluation times and the change in other ECG intervals (PR, RR, QRS, QT) and HR from Day 0 to all other evaluation times.
Expected Total Enrollment:  260

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

• Men and nonpregnant, nonlactating women were 18 years or older. • Women declaring postmenopausal or surgical sterility. • Women of childbearing potential who had a negative serum HCG within 2 weeks of dosing.

• Male subjects weighed at least 60 kg (132 lb), and female subjects weighed at least 48 kg (106 lb). All volunteers weighed within 15% of their ideal body weight (IBW).

Exclusion Criteria:

• Institutionalized • Reported or was known to have done the following: – Used any tobacco product. – Ingested any alcoholic, caffeine or xanthine containing food or beverage within the 48 hours prior to the initial dose of study medication – Consumed grapefruit or grapefruit containing products within 7 days prior to the initial dose of study medication.

– Ingested any vitamins or herbal products within the 48 hours prior to the initial dose of study medication.

– Recently changed dietary or exercise habits significantly • Used any medication (including over-the-counter [OTC]) within the 14 days prior to the initial dose of study medication.

• Used any medication known to alter hepatic enzyme activity within 28 days prior to the initial dose of study medication.

• Received an investigational drug within 30 days prior to the initial dose of study medication.

• History of any significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, or neurologic disease.

• History of drug and/or alcohol abuse within 1 year prior to the study. • Acute illness at the time of either the pre study medical evaluation or dosing.

• Any laboratory results deemed clinically significant by the physician. • Abnormal and clinically relevant ECG tracing. • Donated or lost a significant volume of blood or plasma (>450 mL) within 28 days prior to the initial dose of study medication.

• Allergic or hypersensitive to nebivolol, atenolol, or other β blocking drugs or to moxifloxacin or other quinolone antibiotics.

• History of seizures or cerebrovascular disease.

Florida
      SFBC International, Inc., Miami,  Florida,  33181,  United States

Study chairs or principal investigators

Lawrence A Galitz, MD,  Principal Investigator,  SFBC International   
Will A Sullivan, BS,  Study Director,  Mylan Bertek Pharmaceuticals Inc.   

Study ID Numbers:  NEB122
Last Updated:  September 10, 2005
Record first received:  September 7, 2005
ClinicalTrials.gov Identifier:  NCT00158093
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-09-13