Overview

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

Status:
Completed
Trial end date:
2003-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Mylan Bertek Pharmaceuticals
Treatments:
Atenolol
Fluoroquinolones
Moxifloxacin
Nebivolol
Norgestimate, ethinyl estradiol drug combination
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.