A Safety Evaluation of ECG Intervals and Blood Pressure in Normal Healthy Volunteers After Use of Nebivolol, Atenolol, Moxifloxacin, or Placebo

NCT ID: NCT00158093

Last Updated: 2005-09-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-06-30
• Study Completion Date: 2003-07-31

Brief Summary

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Nebivolol

Intervention Type: DRUG

Atenolol

Intervention Type: DRUG

Moxifloxacin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mylan Bertek Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Principal Investigators

Lawrence A Galitz, MD

Role: PRINCIPAL_INVESTIGATOR

SFBC International

Will A Sullivan, BS

Role: STUDY_DIRECTOR

Mylan Bertek Pharmaceuticals Inc.

Locations

SFBC International, Inc.

Miami, Florida, United States

Countries

United States

Other Identifiers

NEB122

Identifier Type: -

Identifier Source: org_study_id